dimarts, 28 de febrer del 2017

AdvaMed wants HMS to change kickback rules for value-based healthcare

Capitol HillAdvaMed said today it submitted a proposal to the US Dept. of Health & Human Services Office of Inspector General seeking 2 new safe harbors to the anti-kickback statute specific to value-based health care arrangements.

The medical device industry lobbying group said the proposals would help facilitate the health care systems’ shift away from traditional volume-based models and towards value-based payment and delivery.

In the proposals, AdvaMed recommends that the OIG establish 2 new safe harbors for value-based arrangements, the 1st protecting value-based pricing arrangements while the 2nd would protect value-based warranties. The group said that in each case, the arrangement would need to meet certain requirements to qualify for protection.

Each proposed safe harbor include concepts from existing discount and warranty safe harbors, the company said, including transparency and disclosure concepts.

As a possible alternative, AdvaMed said it proposed that the OIG modify existing discount and warranty safe harbors to provide more flexibility and clarity over value-based arrangements that seek to promote optimal patient outcomes and cost efficiency, according to a press release from the lobbying group.

The post AdvaMed wants HMS to change kickback rules for value-based healthcare appeared first on MassDevice.



from MassDevice http://ift.tt/2llNz0i

MicroPort Orthopedics touts high satisfaction, survivorship in Medial-Pivot knee system study

MicroPortMicroPort Orthopedics today released the results from a study of its Medial-Pivot knee system, touting high rates of satisfaction and survivorship at 17 years.

Results from the trial, including long-term clinical and radiographic outcomes, were publsiehd in the medical journal The Knee.

Data from the 325 patient trial exploring patients with knee osteoarthritis who underwent total knee arthroplasty procedures using the company’s Medial-Pivot prosthesis indicated a statistically significant improvement on the Knee Society clinical rating system.

Improvements were also noted on the Western Ontario and McMaster Universities Osteoarthritis index, as well as the Oxford knee score, the company said. A total of 94% of patients were able to perform age-appropriate activities with average knee flexion of 120°, with 98% of patients reporting pain relief to be excellent, very good or good.

A survival analysis of patients in the trial indicated a cumulative success rate of 98.8% at 17 years, the company said.

It has been reported that approximately 20% of patients are not satisfied with the outcome of their total knee replacemen

“I am in my third year of using the Evolution Medial-Pivot Knee System and this publication validates the results that I have seen in my practice. In my experience, the functional outcomes for patients treated with this system have certainly been superior than the systems I’ve used in the past and patients have fewer complaints. When I see them at six or eight weeks follow-up, they’re at a different stage of recovery than I was seeing previously with traditional implant designs. I’ve been exceptionally happy with the results and feel comfortable knowing I am implanting a prosthesis with 98.8% survivorship at 17 years,” Dr. David Backstein of Toronto’s Mount Sinai Hospital said in a prepared statement.

The post MicroPort Orthopedics touts high satisfaction, survivorship in Medial-Pivot knee system study appeared first on MassDevice.



from MassDevice http://ift.tt/2lw2oy9

Elekta wins Health Canada nod for Leksell Gamma Knife Icon SRS system

ElektaElekta (STO:EKTA B) said today it won Health Canada approval for its Leksell Gamma Knife Icon radiosurgery system.

The Stockholm, Sweden-based company touted its Leksell Gamma Knife Icon radiosurgery system as the only SRS system designed specifically for targeting brain tissue. The Icon is the 6th generation version of the radiosurgery system from the Elekta.

“Robust clinical evidence from more than one million procedures supports Gamma Knife as the most precise SRS platform in the world. Icon was designed with multiple technology upgrades that enable improved work flow and efficiencies. As part of our ongoing commitment to improving outcomes for patients and clinicians with treatable neurological conditions worldwide, we are pleased that Icon will now be available in Canada,” North America regional exec VP Bill Yaeger said in a press release.

The Leksell Gama Knife Icon features the company’s Adaptive DoseControl, as well as high-definition motion management technologies to improve treatment accuracy and efficiency, Elekta said.

“We are pleased to soon offer our patients the latest advance in SRS technology. The image guidance and frameless features of Gamma Knife Icon allow us to treat patients who were not candidates for SRS therapy with older technologies. Through our experience participating in the pre-approval validation of this system, we had the opportunity to experience how real-time CT imaging enables sub-millimeter accuracy in targeting tumors. This degree of precision is especially critical when targeting lesions in the brain, where sparing healthy tissue is essential for reducing side effects and protecting normal brain function,” Dr.  Arjun Sahgal of Toronto’s Sunnybrook Health Sciences Centre said in a prepared statement.

Earlier this month, Elekta said it won FDA 510(k) clearance for its Venezia applicator for gynecological brachytherapy, now cleared for the treatment of advanced-stage cervical cancer.

The company’s Venezia device is designed to facilitate pre-defined, consistent needle placement for interstitial brachytherapy and to allow operating clinicians the ability to access tumors that extend outside of the cervix.

The post Elekta wins Health Canada nod for Leksell Gamma Knife Icon SRS system appeared first on MassDevice.



from MassDevice http://ift.tt/2lTRqnf

Align Tech picks up Brazilian distributor

Align TechnologyAlign Technology (NSDQ:ALGN) said today it picked up its Brazilian distributor Align Tech Do Brasil LTDA.

The San Jose, Calif.-based company said the acquisition will allow it to more directly focus on its operations in Brazil, and that as part of the acquisition, it also picked up a small team of employees who will be based in its 1st Latin American office in Sao Paulo, Brazil.

“Brazil is estimated to have approximately 1.4 million new orthodontic case starts each year and employs nearly 20% of world’s dentists. As the world’s second largest market for cosmetic interventions, Brazil represents a tremendous growth potential for Align. The Latin America region is an emerging market for Align and this acquisition will help establish our leadership position in the region and support our long term growth strategy,” Align Americas VP and managing director Lynn Pendergrass said in a press release.

Earlier this month, Align Tech said it expanded workflow options for its iTero intraoral scanner, now expanded to include digital workflow for Nobel Biocare implants.

Customers using the company’s iTero system can now order Nobel Biocare implant cases through detnal labs, which in turn can order NobelProcera single-unit restorations for their doctors.

The post Align Tech picks up Brazilian distributor appeared first on MassDevice.



from MassDevice http://ift.tt/2malYDw

New material illuminates when exposed to chemicals on the body

MIT-living-hydro_0

[Photo courtesy of the researchers]

MIT engineers and biologists teamed up and designed a living-cell-injected hydrogel that can illuminate when exposed to certain chemicals.

The MIT team made wearable sensors using the hydrogel with living cells that lit up after touching a surface with certain chemicals. The new material has the potential to detect chemicals in the environment and the human body.

“With this design, people can put different types of bacteria in these devices to indicate toxins in the environment, or disease on the skin,” said Timothy Lu, associate professor of biological engineering and electrical engineering and computer science, in an MIT news release. “We’re demonstrating the potential for living materials and devices.”

Get the full story on our sister site, Medical Design & Outsourcing.

The post New material illuminates when exposed to chemicals on the body appeared first on MassDevice.



from MassDevice http://ift.tt/2mHZ4A0

Integer Holdings shares dip on Q4

Integer Holdings

Shares in Integer Holdings (NYSE:ITGR) have drooped today after the medical device maker released 4th quarter and full year 2016 earnings that beat earnings per share expectations, but missed on revenue.

The Frisco, Texas-based company posted profits of $7.9 million, or 25¢ per share, on sales of $359.6 million for the 3 months ended December 30, for a huge 131.9% swing from the red on the bottom-line while sales grew 13.2% compared with the same period last year.

Adjusted to exclude 1-time items, earnings per share were 87¢, ahead of consensus on The Street where analysts were looking for sales of $351.7 million.

For the full year Integer posted profits of $6 million, or 19¢ per share, with the bottom-line growing 178% from the red while sales grew a massive 73.3% compared with the previous year. Adjusted earnings per share however were down 13.8% from last year, posting up $2.68 for 2016.

“We had solid performance in the 4th quarter and are pleased with the continued operational and financial stabilization of the business. The successful steps we have taken to integrate and stabilize our business establish a strong foundation and increase our confidence as we move into 2017. We are well-positioned to drive profitable revenue growth as we seek to deliver innovative, cost-effective solutions to our customers and drive shareholder returns over the long-term,” prez & CEO Thomas Hook said in a prepared statement.

The company released outlook for the upcoming year, expecting to see sales between $1.39 billion and $1.43 billion, with adjusted earnings per share between $2.70 and $3.10.

Shares dipped today after the release, down 2.2% to close at $36.15.

The post Integer Holdings shares dip on Q4 appeared first on MassDevice.



from MassDevice http://ift.tt/2mBJOpi

This ingestible sensor is powered by stomach acid

MIT-Energy-Harvest_0MIT and Brigham and Women’s Hospital researchers have announced an ingestible device innovation: a small voltaic cell that can withstand the acidity of fluids in the stomach and still transmit information to a base station.

The small device can stay in the gastrointestinal tract for long periods of time and can produce enough power to operate small sensors or drug delivery devices. Researchers say that this power is a safer and cheaper alternative to the batteries that are used to power devices now.

“We need to come up with ways to power these ingestible systems for a long time,” Giovanni Traverso, a research affiliate at the MIT’s Koch Institute for Integrative Cancer Research, said in an MIT news release. “We see the GI tract as providing a really unique opportunity to house new systems for drug delivery and sensing, and fundamental to these systems is how they are powered.”

Get the full story on our sister site, Medical Design & Outsourcing.

The post This ingestible sensor is powered by stomach acid appeared first on MassDevice.



from MassDevice http://ift.tt/2lQnoly

Surgical Nav group Scopis wins FDA, Health Canada nod for ENT nav system

Scopis MedicalSurgical navigation and augmented reality company Scopis Medical said today it won FDA 510(k) clearance, as well as Health Canada approval for its next-gen surgical navigation designed for ear, nose and throat surgery.

Cambridge, Mass.-based Scopis designs surgical navigation systems using augmented reality technology, with real-world imaging data enhanced by integrated computer-generated images.

“Scopis currently provides surgical navigational systems with augmented reality for ENT, craniomaxillofacial, spine and neurosurgery procedures in 50 countries worldwide. Receiving both FDA 510(K) and MDL clearance enables the immediate commercial launch of our innovative ENT-based products in these significant North American markets. We are excited to welcome Karl, a highly-experienced sales executive in our sector, to lead our commercialization efforts in North America. Operating from our new location in Cambridge, Massachusetts, we are well-prepared to enter these markets,” CEO & founder Bartosz Kosmecki said in a prepared statement.

The company said its devices are supported by its hybrid navigation platform, based on a small portable unit that supports optical, electromagnetic and simultaneous hybrid packing.

“With my experience in the US market, specifically in the ENT space, I’m confident that this breakthrough technology in surgical navigation will have a substantial impact on the ENT community and patients. I am looking forward to bringing these products to surgeons performing sinus procedures in both hospital and office-based settings,” North America sales VP Karl Ring, who joined the company as part of the launch, said in a press release.

The post Surgical Nav group Scopis wins FDA, Health Canada nod for ENT nav system appeared first on MassDevice.



from MassDevice http://ift.tt/2lvz76I

BioCardia, Johns Hopkins treats first patient with CardiAmp cell therapy in Phase III trial

BioCardia, Johns Hopkins treats first patient with CardiAmp cell therapy in Phase III trialJohns Hopkins, the Maryland Stem Cell Research Fund and BioCardia (NSDQ:BCDA) said today that the 1st patient has been treated in a pivotal Phase III trial of the CardiAmp cell-based therapy for the treatment of ischemic heart failure.

The investigational therapy was designed to deliver a dose of a patient’s own bone marrow cells directly to the area of cardiac dysfunction after a heart attack, according to BioCardia.

Get the full story at our sister site, Drug Delivery Business News.

The post BioCardia, Johns Hopkins treats first patient with CardiAmp cell therapy in Phase III trial appeared first on MassDevice.



from MassDevice http://ift.tt/2lvSxsb

MassDevice.com +5 | The top 5 medtech stories for February 28, 2017

plus5-node

Say hello to MassDevice +5, a bite-sized view of the top five medtech stories of the day. This feature of MassDevice.com’s coverage highlights our 5 biggest and most influential stories from the day’s news to make sure you’re up to date on the headlines that continue to shape the medical device industry.

Get this in your inbox everyday by subscribing to our newsletters.

 

5. TearLab readies for reverse split

MassDevice.com news

Shares in TearLab Corp. said last week that its board approved a 1-for-1 reverse split of its common stock. The company’s shares have fallen nearly 20% since the beginning of the month.

The San Diego, Calif.-based company’s move reduced the total number of authorized shares of its common stock from 95 million t0 9.5 million, according to regulatory filings. Read more


4. Motus GI raises $30m for Pure-Vu colonoscopy system

MassDevice.com news

Motus GI said today that it closed a $30 million private placement which it plans to use in support of the commercial launch of its Pure-Vu colonoscopy system.

The lead investor in the placement was Perceptive Advisors, joined by Orchestra Medical Ventures, Ascent Biomedical Ventures, Jacobs Investment Company, GJG Life Sciences and Pura Vida Investments. Read more


3. Elixir Medical’s DeSyne stent tops Medtronic’s Endeavor after 5 years

MassDevice.com news

Elixir Medical’s novolimus-eluting stent, DeSyne, outperformed Medtronic‘s zotarolimus-eluting stent, Endeavor, according to long-term data from Elixir’s Excella II trial.

The study enrolled 210 patients with 2 or more de novo lesions in 2 different epicardial vessels. Researchers randomly assigned patients in a 2:1 ratio to the novolimus-eluting stent or the zotarolimus-eluting stent. Read more


2. Boston Scientific gets in on $45m private placement for Corindus Vascular Robotics

MassDevice.com news

Boston Scientific got in on a $45 million private placement for Corindus Vascular Robotics and the CorPath GRX device it’s developing for cardiac and peripheral vascular procedures.

New investors BioStar Ventures, Consonance Capital and Hudson Executive Capital also participated, joining existing backers HealthCor Partners Management and Royal Philips. Read more


1. Metallurgy firm exec cops to $75k bribe of Stryker engineer

MassDevice.com news

An executive with a New York metallurgy firm, Sanova LLC, pleaded guilty yesterday to bribing an engineering director at Stryker to win a multi-million dollar contract, according to federal prosecutors.

Eugene Ostrovsky, vice president and partner at Sanova, admitted that he paid the roughly $70,000 in bribes to Daniel Lawrynowicz in 2012 and 2013 to help Sanova land a contract with Stryker’s Howmedica division in New Jersey, according to the U.S. District Attorney for New Jersey’s office. Read more

The post MassDevice.com +5 | The top 5 medtech stories for February 28, 2017 appeared first on MassDevice.



from MassDevice http://ift.tt/2lvNYhp

Synergy Biomedical wins CE Mark for Biosphere putty

Synergy Biomedical wins CE Mark for Biosphere puttySynergy Biomedical said today that it won CE Mark clearance in the European Union for its Biosphere putty bone graft.

The company’s Biosphere putty is a synthetic bone graft that uses a type of bioactive glass in combination with a moldable phospholipid carrier.

Previous in vitro studies have shown that the bone graft product can significantly improve the healing potential of bioactive glass thanks to its spherical particle shape, Synergy Biomedical reported.

“Since its introduction, Biosphere putty has been very well received by surgeons due to its successful clinical use and excellent intraoperative handling,” president & CEO Mark Borden said in prepared remarks. “We are very pleased to receive our CE Mark and are looking forward to introducing a truly next generation, synthetic bone graft product to the European community.”

According to the graft’s indication in Europe, Biosphere putty was designed to be used to fill bony voids or gaps of the skeletal system. The product was cleared to be used for interbody and posterolateral fusion, as well as general bone defect filling.

“When it comes to selecting the best bone graft strategy for each patient, there are a wide array of options for surgeons. Biosphere putty is an elegant bone graft solution that is based on scientifically valid principles,” Dr. Erik Westerlund, from the St. Francis Hospital, said. “It applies an advanced and refined understanding of bioactive glass to drive a purposeful cellular level response and to provide an ideal physical environment for even and predictable bone ingrowth. My clinical experience with Biosphere putty over the past 2 years has been excellent, with consistently successful long-term outcomes in a wide range of spinal applications. It is an extremely thoughtful and equally versatile bone graft solution.”

The post Synergy Biomedical wins CE Mark for Biosphere putty appeared first on MassDevice.



from MassDevice http://ift.tt/2lQrJp0

MicroPort, undaunted by price caps, enters India’s stent market

MicroPortMicroPort has entered the Indian market only days after the country’s National Pharmaceutical Pricing Authority imposed a price cap on coronary stents.

The Shanghai-based company said its Firehawk Rapamycin target eluting coronary stent system was successfully used in a procedure in Mumbai earlier in the month, marking the 1st time the device saw use in the country.

The procedure was performed at H. J. Doshi Ghatkopar Hindu Sabha Hospital in Mumbai, by Dr. Anil Potdar, according to a press release. The company touted the Indian market as having the 3rd largest amount of PCI cases in the world, and promised future expansions in the region.

“In the future, Microport will further expand the India market to provide ideal medical solutions for local patients suffering from cardiovascular disease,” the company wrote in a press release.

The market cap has made it tricky for global giants like Abbott, who find it difficult to maintain their premium devices, according to a Business Standard report.

On Feb. 13, the NPPA passed a price cap of $108.88 (INR ₹7,260) for bare metal stents, and $443.91 (INR ₹ 29,600) for drug-eluting stents, which are used in nearly 90% of angioplasty procedures. More advanced, biodegradable stents were also capped at $443.91.

Last December, Lombard Medical Technologies (NSDQ:EVAR) said that Microport invested $15 million as part of a partnership deal between the 2 companies.

Through the partnership, Lombard said it would seek to accelerate commercialization of its Aorfix and Altura stent grafts for treating abdominal aortic aneurysms. Microport will gain exclusive marketing rights for both products in China and Brazil, as well as a license to manufacture the products for the Chinese market.

As part of the deal, Microport and Lombard said they entered a component supply manufacturing deal, with Microport manufacturing components for the Altura and Aorfix at its Shanghai facilities.

The post MicroPort, undaunted by price caps, enters India’s stent market appeared first on MassDevice.



from MassDevice http://ift.tt/2lQnlpS

Globus shares dip on mixed-bag Q4, FY2016 earnings

Globus MedicalShares in Globus Medical (NYSE:GMED) have fallen slightly today after the medical device maker missed earnings per share expectations, but topped revenue with its 4th quarter and full fiscal year 2016 earnings.

The Audubon, Penn.-based company posted profits of $24.3 million, or 25¢ per share, on sales of $151.6 million for the 3 months ended December 31, for a bottom-line decline of 35.4% while sales grew 6.3% compared with the same period last year.

Adjusted to exclude 1-time items, earnings per share were 31¢, just below the 33¢ consensus on Wall Street, where analysts were expecting to see sales of $149 million.

For the full year, the company posted profits of $104.3 million, or $1.08 per share, on sales of $564 million. That equates to a bottom-line decline of 7.5% while sales grew 3.5% compared with the previous fiscal year. Adjusted earnings per share clocked in at $1.19, up 5.3% from the previous year.

“Fourth quarter sales were $151.6 million, a year-over-year increase of 6.3%.  Despite our increased spending in support of our pending robotics and trauma launches, our adjusted EBITDA margins was an outstanding 37.7%.  We also delivered EPS of $0.25 and non GAAP EPS of $0.31. During the fourth quarter, we continued to make progress with product development, sales force development and integration of Alphatec’s international business.  We also further expanded our in-house manufacturing capacity.  We are proud of our innovation and product development efforts, which resulted in a total of 17 new product launches in 2016.  We have addressed our sales force expansion challenges and are optimistic that we will return to more robust growth rates in the second half of 2017. We also remain confident in our long-term growth prospects and our ability to sustain industry-leading profitability by continuing to execute on our strategy of rapid product introduction, expansion of our U.S. and international sales footprints, and diligent expense control,” CEO David Paul said in a press release.

Globus Medical released outlook for the upcoming year, expecting to see revenue of $625 million and non-GAAP earnings per share of $1.27.

Shares have dipped slightly today, down 0.6% to trade at $28.42 as of 12:56 p.m. EST.

The post Globus shares dip on mixed-bag Q4, FY2016 earnings appeared first on MassDevice.



from MassDevice http://ift.tt/2lkJzNC

Gamida Cell touts first patient treated in Phase III NiCord trial

Gamida Cell touts first patient treated in Phase III NiCord trialGamida Cell said today that the 1st patient has been treated in the Phase III registration trial of its NiCord cell graft for patients with blood cancer. The treatment is a graft derived from umbilical cord blood which has been expanded and enriched with stem and progenitor cells, according to the company.

The Jerusalem-based company’s cell graft was designed as an alternative to bone marrow transplantation for patients with blood cancer who do not have a fully matched donor.

Get the full story at our sister site, Drug Delivery Business News.

The post Gamida Cell touts first patient treated in Phase III NiCord trial appeared first on MassDevice.



from MassDevice http://ift.tt/2lkX1RA

What is Good Clinical Practice?

imarcDo you know why rules, regulations and standards exist? What exactly is Good Clinical Practice and how does this help protect patients and data integrity?

Protecting patients is at the core of clinical research and one of the ways research teams can ensure human subjects are protected is through holding up rules, regulations and standards set forth. Good clinical practice (GCP) is something that encompasses all these things because it is:

An attitude of credible excellence in research that provides a standard for clinical study design, implementation, conduct and analysis

Many cornerstone events have occurred in history to make clinical research what it is today. Often times the biggest events in patient protection had roots in some of the most unethical tragedy. We have a whitepaper devoted to the key principles that make up good clinical practice, and how to take “good to great” in clinical research.

Since this topic is so important we’ve created a one page guide you can print for free which defines GCP, describes what makes up GCP, and ultimately reminds us that the responsibility for clinical research ethics rests on all of our shoulders.

Use our infographic as a memento- the only way to practice clinical research is with Good Clinical Practice!

The opinions expressed in this blog post are the author’s only and do not necessarily reflect those of MassDevice.com or its employees.

The post What is Good Clinical Practice? appeared first on MassDevice.



from MassDevice http://ift.tt/2lQeuot

5 mistakes found in cloud-connected medical devices

Cloud-connected medical technology will have a significant impact on the healthcare system. Network-connected medical devices create a world of instant information, warns Dana Good senior software engineer at Stratos Product Development.

Good recently presented a podcast on Cloud-connected Medical Device Development Challenges and Solutions.

She says
capabilities of cloud-connected devices allow medical technology manufacturers to offer data to clients, even if the client has no computing hardware. But capability also brings complexity. There are significant design challenges and a steep learning curve. Companies developing systems need to understand the common errors in cloud-connected medtech to avoid, as well as the best practices and careful planning required for success.

See the five most common cloud-connected mistakes at our sister site, Medical Design & Outsourcing. 

The post 5 mistakes found in cloud-connected medical devices appeared first on MassDevice.



from MassDevice http://ift.tt/2m9pRsh

FDA asks Titan for more info before clinical trial of ropinirole implant

FDA asks Titan for more info before clinical trial of ropinirole implantTitan Pharmaceuticals (NSDQ:TTNP) said today that the FDA put a hold on the clinical trial of its ropinirole implant and told the company to submit more information to the federal watchdog.

After it completed an initial review of the implant’s Investigational New Drug application, the FDA asked Titan for final release test data on its ropinirole implant and the applicator used to insert the implant. Titan also needs to identify a principal investigator for the study, although the company said it is in the process of qualifying the participating clinical sites.

Get the full story at our sister site, Drug Delivery Business News.

The post FDA asks Titan for more info before clinical trial of ropinirole implant appeared first on MassDevice.



from MassDevice http://ift.tt/2mGYPWb

Insulet slides on Q4 earnings miss

InsuletInsulet (NSDQ:PODD) shares are under pressure this morning after the diabetes company missed expectations for its 4th-quarter earnings, despite beating Wall Street’s consensus sales forecast.

Billerica, Mass.-based Insulet narrowed its losses by -66.6%, to -$9.1 million, or -16¢ per share, on sales growth of 23.6% to $103.6 million for the 3 months ended Dec. 31, compared with Q4 2015. Analysts on The Street were looking for losses of just -6¢ on sales of $100.6 million.

Investors reacted by pushing PODD shares down -3.8% to $44.42 apiece today in late-morning activity.

Insulet reported full-year losses of -28.9 million, or -48¢ per share, on sales of $367.0 million, cutting its losses by -60.7% on sales growth of 39.1% compared with 2015.

“We continue to successfully execute on our strategy as evidenced by our 2016 revenue results, which exceeded our expectations,” chairman & CEO Patrick Sullivan said in prepared remarks. “With our differentiated platform and outstanding commercial and operational execution, we achieved significant growth across all business lines, driving 39% revenue growth and a 7-point gross margin improvement year-over-year.

“Insulet is very well-positioned for continued growth in 2017. We remain focused on our large, unpenetrated market opportunity in the diabetes space and are on track to achieve our 5-year targets of $1 billion in revenue and 65% gross margin, which we believe will deliver substantial returns for shareholders. We look forward to continued success in executing our key initiatives to drive growth and shareholder value, while improving the lives of people with diabetes around the world,” Sullivan said.

Insulet said it expects to put up sales of $420 million to $440 million this year and $96 million to $99 million for the 1st quarter.

The post Insulet slides on Q4 earnings miss appeared first on MassDevice.



from MassDevice http://ift.tt/2mprTFf

TearLab readies for reverse split

TearLab readies for reverse splitShares in (NSDQ:TEAR) said last week that its board approved a 1-for-1o reverse split of its common stock. The company’s shares have fallen nearly 20% since the beginning of the month.

The San Diego, Calif.-based company’s move reduced the total number of authorized shares of its common stock from 95 million t0 9.5 million, according to regulatory filings.

TEAR shares were trading at $5.30 in mid-morning activity today, down -7.7%.

Get the full story at our sister site, Drug Delivery Business News.

The post TearLab readies for reverse split appeared first on MassDevice.



from MassDevice http://ift.tt/2mANnvK

Motus GI raises $30m for Pure-Vu colonoscopy system

Motus GI raises $30m for Pure-Vu colonoscopy systemMotus GI said today that it closed a $30 million private placement which it plans to use in support of the commercial launch of its Pure-Vu colonoscopy system.

The lead investor in the placement was Perceptive Advisors, joined by Orchestra Medical Ventures, Ascent Biomedical Ventures, Jacobs Investment Company, GJG Life Sciences and Pura Vida Investments.

The Tirat Carmel, Israel-based company won FDA clearance in Sept. 2016 for its device used to clean poorly-prepped colons during colonoscopies.

“We are excited with the outcome of this oversubscribed offering. The proceeds from the offering are expected to give us the capital to proceed with the U.S. commercial introduction of the Pure-Vu system and build awareness and support for the Pure-Vu system’s benefits amongst providers, patients and payers,” CEO Mark Pomeranz said in prepared remarks. “Inadequate bowel prep is one of the greatest challenges to effective, successful colonoscopies. It leads to missed adenomas and procedures needing to be repeated earlier than the recommended guidelines, adding cost to the healthcare system. The Pure-Vu system’s ability to rapidly clean the colon during the colonoscopy procedure has the potential to improve the quality of the exam, increase patient satisfaction and reduce costs.”

Motus is introducing the system on a pilot basis, the company said, and expects to complete its 1st U.S. in-hospital and outpatient installations in the 1st quarter of this year.

“Motus’ Pure-Vu system has the potential to significantly improve colonoscopy , which is one of the world’s most common medical procedures with over 15 million performed just in the US every year,” Motus chairman & managing partner of Orchestra Medical Ventures, David Hochman, added. “The proceeds of this financing will help us fulfill the enormous potential of this solution, including clinical study initiatives to support expansion of the Pure-Vu system’s indication for use in colonoscopies with a significantly reduced preparation for patients who find it difficult to comply with and tolerate conventional, purgative-based prep regimens. We believe that dramatically reducing the bowel prep burden, which is one of the major barriers to colonoscopy procedures, would be welcomed by all.”

Last November, the company touted data from a clinical trial that evaluated its device in 50 colonoscopies, using a regimen of an 18-24 hour liquid diet and bisacodyl tablets designed to deliberately create inadequately prepped colons.

The team found that the Pure-Vu system significantly increased the number of participants with an adequate cleansing level from 31% at baseline to 98% after use of the device.

The post Motus GI raises $30m for Pure-Vu colonoscopy system appeared first on MassDevice.



from MassDevice http://ift.tt/2lkobrM

Elixir Medical’s DeSyne stent tops Medtronic’s Endeavor after 5 years

Elixir MedicalElixir Medical's DeSyne stent tops Medtronic's Endeavor after 5 years‘s novolimus-eluting stent, DeSyne, outperformed Medtronic‘s (NYSE:MDT) zotarolimus-eluting stent, Endeavor, according to long-term data from Elixir’s Excella II trial.

The study enrolled 210 patients with 2 or more de novo lesions in 2 different epicardial vessels. Researchers randomly assigned patients in a 2:1 ratio to the novolimus-eluting stent or the zotarolimus-eluting stent.

Get the full story at our sister site, Drug Delivery Business News.

The post Elixir Medical’s DeSyne stent tops Medtronic’s Endeavor after 5 years appeared first on MassDevice.



from MassDevice http://ift.tt/2m8r8QG

Boston Scientific gets in on $45m private placement for Corindus Vascular Robotics

Corindus Vascular RoboticsBoston Scientific (NYSE:BSX) got in on a $45 million private placement for Corindus Vascular Robotics (NYSE:CVRS) and the CorPath GRX device it’s developing for cardiac and peripheral vascular procedures.

New investors BioStar Ventures, Consonance Capital and Hudson Executive Capital also participated, joining existing backers HealthCor Partners Management and Royal Philips (NYSE:PHG).

“We are pleased to announce this financing and appreciate the support of our new and existing investors,” president & CEO Mark Toland said in prepared remarks. “The additional capital will allow us to continue the momentum created by strong interest in the recent launch of our next-generation CorPath GRX system and our expansion into Japan with an exclusive distribution agreement with MC Healthcare.”

Corindus said it expects to close the funding round in March.

The Waltham, Mass.-based company won FDA 510(k) clearance for the next-gen CorPath GRX system last October, adding several features including the ability to control the guide catheter in 1mm increments to precisely position balloon or stent catheters during percutaneous coronary interventions.

CVRS shares jumped 13.4% in pre-market trading today, to 75¢ apiece.

The post Boston Scientific gets in on $45m private placement for Corindus Vascular Robotics appeared first on MassDevice.



from MassDevice http://ift.tt/2mAdhjh

Metallurgy firm exec cops to $75k bribe of Stryker engineer

Gavel, handcuffsAn executive with a New York metallurgy firm, Sanova LLC, pleaded guilty yesterday to bribing an engineering director at Stryker (NYSE:SYK) to win a multi-million dollar contract, according to federal prosecutors.

Eugene Ostrovsky, vice president and partner at Sanova, admitted that he paid the roughly $70,000 in bribes to Daniel Lawrynowicz in 2012 and 2013 to help Sanova land a contract with Stryker’s Howmedica division in New Jersey, according to the U.S. District Attorney for New Jersey’s office.

Lawrynowicz’s LinkedIn page lists him as a 15-year Stryker employee who is senior director of advanced engineering, leading “a team of 41 engineers and scientists at the Mahwah, N.J. facility dedicated to supporting the Recon Business Units.”

Ostrovsky, who pleaded guilty to violating the Federal Travel Act, faces 5 years in prison, plus a $250,000 fine or twice the gross gain or loss, the prosecutors said. He will also forfeit $1.1 million in connection with the plea; Ostrovsky is slated for sentencing June 29.

Lawrynowicz, who was also charged with bribery in March 2016, similarly faces 5 years in prison and a $250,000 fine.

According to the complaint filed against him, the FBI in December 2015 recorded Lawrynowicz on calls with an unnamed representative from Sanova in which they allegedly discuss concealing about $75,000 in bribes ahead of a fictitious audit of Sanova:

Representative One: “I am more worried about that $75k in cash that eh you know that we gave you, I don’t know if that ever comes up, or we deny it right, obviously.”

Lawrynowicz: “Yeah, Yeah … when is that happening?”

Representative One: “Its ongoing, they called us to say they are auditing us and they just showed up…”

Lawrynowicz: “Let’s get a story together so that ah you know it all has legs and a tail.”

During a call the next day the pair allegedly revisited the subject, discussing any potential links to a consulting company owned byLawrynowicz, according to the complaint:

Representative One: “Oh you are talking about the eh $75K cash that we gave for, after [medical device company] contract?”

Lawrynowicz: “Yeah” … “what link do you have documented to [consulting company]? “What does [consulting company] represent within any of the files of [Sanova]? …”What is the story, that eh, what services did [consulting company] render to make sure that we are all singing the same tune, if there is a dialogue?”

Representative One: “I know I took out my $25K in a safe way … I don’t know if that is as important, just to make sure that yours was not appropriated in any kind of visible way, I mean tell me that you left it in cash or at least if you put it somewhere that you put it an untraceable account …”

Lawrynowicz: “Yeah, yeah, it never made it into any account … there is no record of any kind of deposit.”

Representative One: “That should be okay, I guess…”

Lawrynowicz: “From my end, I’ve been very cognizant from not creating any raised eyebrows kind of scenarios, so it’s all been appropriately handled.”

Ostrovsky’s problems aren’t over either, according to the Tampa Bay Times, which reported in 2014 that he and another Sanova partner, Anatoly Samgorodsky, are facing charges that they bribed a U.S. Energy Dept. official to win a $3.4 million contract to research nuclear reactor fuel rods.

 

The post Metallurgy firm exec cops to $75k bribe of Stryker engineer appeared first on MassDevice.



from MassDevice http://ift.tt/2mA1u4v

South African medical device companies have new licensing deadline

Emergo GroupBy Stewart Eisenhart, Emergo Group

South Africa’s Medicines Control Council (MCC) has set a six-month deadline for domestic medical device and IVD manufacturers and distributors to apply for licensing in order to legally operate in the country.

Get the full story here at the Emergo Group’s blog.

The opinions expressed in this blog post are the author’s only and do not necessarily reflect those of MassDevice.com or its employees.

The post South African medical device companies have new licensing deadline appeared first on MassDevice.



from MassDevice http://ift.tt/2lu5z9s

dilluns, 27 de febrer del 2017

Orthofix shares steady on Q4, FY2016 Street-beating earnings release

OrthoFixShares in Orthofix (NSDQ:OFIX) have stayed steady today after the medical device maker beat expectations from Wall Street with its 4th quarter and full fiscal year 2016 earnings results.

The Lewisville, Texas-based company posted losses of $3.2 million, or 18¢ per share on sales of $108.5 million for the 3 months ended December 31. The company saw the bottom-line shrink nearly 200% from its posted $3.4 million in profits during the same quarter last year, while sales grew 3.7%.

After adjusting to exclude 1-time items, earnings per share were 42¢, 5¢ ahead of consensus on Wall Street where analysts were expecting the company to post sales of $106 million.

For the full year, Orthofix posted sales of $3.1 million, or 17¢ per share, on sales of $409.8 million for bottom-line growth of over 200% while sales grew 3.4% compared with the previous fiscal year.

Adjusted to exclude 1-time items, earnings per share were $1.46, ahead of consensus on Wall Street, which expected to see sales of $408 million.

“We are very proud of what we accomplished in 2016 and are encouraged by our momentum at year-end. We improved our performance during the year in almost every aspect of our business and exited an era of heavy investment with a rebuilt infrastructure, robust compliance program, rigorous financial controls, strong balance sheet, excellent free cash flow and great momentum in our BioStim and Extremity Fixation businesses. Looking ahead to the next chapter for Orthofix, we are now well positioned and committed to execute on both organic and inorganic strategic opportunities focused on accelerating shareholder value creation,” prez & CEO Brad Mason said in a prepared statement.

Orthodox also released guidance for the upcoming year, expecting to net revenue between $407 and $411 million, with adjusted earnings per share for the year between $1.48 and $1.58.

Shares have stayed steady in after hours trading after closing up 0.3% at $38.13.

The post Orthofix shares steady on Q4, FY2016 Street-beating earnings release appeared first on MassDevice.



from MassDevice http://ift.tt/2lsJV5p

Mederi touts meta-study of Stretta GERD treatment device

Mederi TherapeuticsData from a meta-analysis study of Mederi Therapeutics Stretta device released this week indicate that treatments with the device reduced heartburn and improved health-related quality of life scores for patients with gastroesophageal reflux disease.

The company’s Stretta catheter system applies low-poet radio frequency energy to remodel the lower esophageal sphincter to restore natural barrier function and reduce spontaneous regurgitation caused by transient relaxations of the sphincter.

In the study, researchers analyzed results from 28 studies of the Stretta system, including data from 2,468 unique Stretta patients. Results indicate an average 1.43 improvement to pooled heartburn standardized scores with health-related quality of life scores improving by 14.6.

The rate of erosive esophagitis was lowered by 24%, data indicated, while esophageal acid exposure was reduced by an average of 3.01. Lower esophageal sphincter basal pressure was increased by an average of 1.73, according to the study.

Researchers concluded that due to the improved endpoints in the trial, treatment with the Stretta device “therefore should be considered as a viable alternative in managing GERD.

The post Mederi touts meta-study of Stretta GERD treatment device appeared first on MassDevice.



from MassDevice http://ift.tt/2l68Xeu

MedCrypt and QuiO partner to protect devices from cyberattacks

cybersecurityMD

[Image courtesy of Blogtrepreneur on Flickr, per Creative Commons 2.0 license]

MedCrypt and QuiO have announced an integration partnership for a set of cloud-connected injection devices known as the Smartinjector devices to provide safe data transfers of patient prescriptions and injections.

OuiO will receive software security with this partnership for its Si One, for specialty drugs, and Si Pen, for diabetes patients. MedCrypt’s software will be able to sync with the drug delivery sensors to automatically send real-time dosing data. MedCrypt’s software will help monitor device usage for suspicious behavior. Encrypted and properly signed data will also be able to be communicated through ConnectedRx, QuiO’s cloud platform.

“It’s critical that our bi-directional communication channel remains secure at all times, from both a privacy and safety standpoint,” said QuiO co-founder and CEO Alexander Dahmani. “We’re proud to be working with MedCrypt because their technology has been successfully used to secure some of the highest-risk medical devices in the market and we want every available defense in today’s evolving cybersecurity landscape.”

The post MedCrypt and QuiO partner to protect devices from cyberattacks appeared first on MassDevice.



from MassDevice http://ift.tt/2lhIrdh

Medtronic touts 5-year economic analysis data from CRT-focused Reverse study

Medtronic Medtronic (NYSE:MDT) today released 5-year economic analysis data from its Reverse study of patients treated with cardiac resynchronization therapy devices, touting longer lifespans and long-term cost efficiency compared to optimal medical therapy.

Results from the Reverse trial were published in the Journal of the American College of Cardiology: Heart Failure.

“These new data expand upon the current evidence and guidelines for the treatment of heart failure, by showing that CRT in patients with mildly symptomatic heart failure is beneficial, both from a clinical perspective, as well as from a financial perspective. Reverse confirms that implanting CRT earlier slows the progression of heart failure, reduces heart failure-related hospitalizations and deaths, and prolongs life, all while being very cost-effective,” Dr. Michael Gold of the Medical University of South Carolina said in a prepared release.

Fridley, Minn.-based Medtronic touted Reverse as the largest study looking to explore the long-term clinical impact and survival benefit of CRT-D devices compared with CRT pacers, and as the 1st study to report cost-efficiency of CRT when implanted early in the disease state.

Economic analysis data from the 610-patient prospective, randomized, double-blinded Reverse study indicated that, under a Medicare setting, CRT is a cost-effective option for patients with mild-heart failure.

Medtronic said that results showed that patients receiving CRT therapy had an incremental cost effectiveness ratio of $8,840 per quality-adjusted life year when compared to those not receiving CRT therapy. Data also indicated that patients treated with CRT-D devices showed a 2.77 year improvement in survival compared to CRT-P devices, resulting in an IER of $43,678 per QALY over a patient’s lifetime.

Data also indicated that CRT use delays disease progression, making CRT-Ds effectively cost-neutral compared to implanting an ICD initially, with a CRT-D to follow as the disease progresses.

“While CRT has long been established as a therapy that significantly improves outcomes for patients with heart failure, it is consistently underutilized. Not only does Reverse demonstrate the clinical benefit of CRT, it also quantifies the economic value of CRT, providing hospital systems with valuable information to help make informed decisions about CRT as a treatment option and the optimal timing of CRT for patients with heart failure. Ultimately, the goal is to increase value by improving patient outcomes and optimizing costs,” Medtronic heart failure biz GM Dr. David Steinhaus said in a press release.

The post Medtronic touts 5-year economic analysis data from CRT-focused Reverse study appeared first on MassDevice.



from MassDevice http://ift.tt/2lZnnw6

Philips wins FDA clearance for ElastQ liver imaging tech

Philips wins FDA clearance for ElastQ liver imaging techRoyal Philips (NYSE:PHG) said today that it won 510(k) clearance from the FDA for its ElastQ imaging technology, which allows for simultaneous imaging and assessment of tissue stiffness to diagnose liver conditions such as hepatitis B and cirrhosis.

The company’s technology uses shear wave elastography to focus sound waves and assess soft tissue stiffness, according to Philips.

Traditionally, healthcare practitioners perform liver biopsies to determine the stage of liver disease and these procedures can be costly and painful. Philips touts its ultrasound technology as a non-invasive alternative to conventional liver biopsies.

“Philips aims to provide the tools necessary for assessing and managing chronic conditions that so many people face, and liver disease is no exception,” ultrasound business leader Vitor Rocha said in prepared remarks. “We know that liver disease is a growing health concern around the globe, and we are committed to pioneering innovations like ElastQ Imaging to create our ultimate ultrasound liver solution that offers exceptional clinical performance, further improving patient care.”

The company claimed that its ElastQ imaging technology offers a larger field of view than competitors and provides real-time feedback and intelligent analysis, along with quantitative measurements and multiple sample points.

“There is a significant population at risk for liver disease that may not even know it,” radiologist Dr. Richard Barr added. “As a radiologist, I see every day how important liver assessment is becoming, and I’m hopeful that this solution will help patients get the diagnosis, monitoring and treatment they need.”

PHG shares were trading at $30.13 apiece in mid-afternoon trading today, up 1.5%.

The post Philips wins FDA clearance for ElastQ liver imaging tech appeared first on MassDevice.



from MassDevice http://ift.tt/2lP3W7f

Viveve Medical reports success treating vaginal laxity

viveveViveve Medical recently published the results of a clinical study of its Viveve I treatment in the Journal of Sexual Medicine, showing that women who received the treatment reported being more likely to have no vaginal laxity.

The Viveve Treatment of the Vaginal Introitus to Evaluate Efficacy study is one of the first studies to study the safety and efficacy of energy-based procedures in gynecological applications that was randomized, single-blinded and sham-controlled. It was meant to show the efficacy and safety of Viveve treatment as opposed to a sham control procedure for vaginal introital laxity treatment. The study included two groups of women, one that was going to receive the treatment and the other that was going to be the sham group.

The Viveve I treatment uses cryogen-cooled monopolar radiofrequency (CMRF) to deliver gentle volumetric heating while cooling delicate surface tissue, allowing collagen to form. It is designed for women who are suffering from the changes in their bodies after giving birth. The treatment can be done in an outpatient clinic in a 30-minutes.

Get the full story on our sister site, Medical Design & Outsourcing.

The post Viveve Medical reports success treating vaginal laxity appeared first on MassDevice.



from MassDevice http://ift.tt/2mx7N9b

4 Key Insights When Raising Money for Your Medtech Startup: Interview with Bruce Shook, CEO of Intact Vascular

bruceshookWelcome to the Medsider interview series, a regular feature at MassDevice. All interviews are conducted by Scott Nelson, Founder of Medsider and Group Director for WCG. We hope you enjoy them!

Bruce Shook joined Intact Vascular in 2014 as President and CEO. A highly-experienced, medical device executive with more than 30 years of industry experience, Bruce was previously Co-founder, Director, President, and CEO of Neuronetics, which is a privately held medical device company that markets a non-invasive brain stimulation technology for the treatment of depression.

Previously, Shook was Co-founder, Director, President, and CEO at Neuron Therapeutics, a venture-backed company developing a drug/device product for the treatment of CNS disorders. Before that, he served as President of Abiomed, where he successfully obtained a PMA approval for the first, FDA-approved ventricular assist device. Bruce developed cardiac pacing and anti-arrhythmia products at Cordis Corporation as well.

Bruce holds advanced degrees in Biomedical Engineering from Columbia University and Business Administration from the MIT Sloan School of Management. He earned a B.S. degree in Chemical Engineering from Penn State University.

Here are some of the things we’re going to learn in this interview with Bruce:

  • After a storied medtech career, the device that Bruce is most proud of.
  • The origin story for the Tack Endovascular System and how it’s different than current peripheral vascular stents.
  • Bruce’s transition from Cordis to Abiomed and what he learned both personally and professionally.
  • Why Bruce decided to pursue an MBA from MIT after his run with Abiomed.
  • How Bruce and his team at Neuron Therapeutics responded after their failed clinical trial.
  • The lessons Bruce learned while trying to gain insurance coverage and reimbursement for the TMS device with Neuronetics.
  • Bruce’s advice for other medtech entrepreneurs that need to raise money beyond the “friends and family” round.
  • Bruce’s favorite business book, the CEO he most admires, and the advice he’d give to his 25-year-old self.

The following transcript is based on an audio interview with Bruce Shook and Scott Nelson.  It has been modified for enhanced readability.

Scott Nelson: Hey Bruce, welcome to the program, we appreciate you coming on.

Bruce Shook: Thanks, great to be here.

Scott Nelson: Let’s start with a summary of your career because it’s been a pretty fascinating ride. From your early days at Cortis through your closed to 10 years of experience at Abiomed, another ten plus years at Neuronetics, now where you’re at Intact Vascular, joining back in mid-2014. It’s probably like asking a parent, “Who is your favorite child?” But I’ll ask you the question nonetheless. Do you have a favorite medical device or one that stands out looking back at the entirety of your medtech career?

Bruce Shook: If you asked me which one had the most profound effects on people’s lives, I’d have to say it was the NeuroStar System that we developed at Neuronetics. Major Depressive Disorder is a ubiquitous disease, and it’s incredibly debilitating. I didn’t fully appreciate that when we started that company but as we got into it, I was shocked at how debilitating it is. We developed an entirely new way to treat that disease at Neuronetics and it was highly effective.

I’m incredibly pleased and proud that it helped so many people with depression. I think the entire team at Neuronetics has made a fantastic contribution to the mental health field. If you ask me which technology resulted in the largest business opportunity, I’d have to say it with ventricular assist device we developed at Abiomed. That product was the very first VAD ever FDA approved, and it formed a cornerstone of sorts for what has become a very successful business.

Scott Nelson: It’s good to get your thoughts on that. I’m sure there’s probably hard to decide or have a definitive answer to that question. To be quite honest, I was loosely familiar with Neuronetics and NeuroStar. But then, of course, leading up to our conversation here, I did a fair amount of research, and it seemed like a pretty impressive journey over the course of about ten years.

Let’s level set things for the audience. Can you provide an overview of Intact Vascular as we see it today? Then also, as a follow-up question, how does your device work and what does it treat?

Bruce Shook: Intact is a company that’s entirely focused on developing endovascular innovations in the peripheral vascular space. Our flagship technology is called the Tack Endovascular System, and this is a system for the repair of arterial dissections that occur following angioplasty. They’re essentially flaps that peel off the vessel walls, the function of balloon angioplasty.

The technology itself consist of implants, we call the “tack”, which are small self-expanding nitinol devices. They’re just about six millimeters long, so they’re quite small and a novel delivery system to deliver them into the arteries. The delivery system houses multiple “tacks” and allows very targeted repair of the vessel right after the angioplasty procedure is complete.

Some of the advantages of the tack versus stenting are that it’s designed to leave much less metal in the artery; 70 to 80% less metal. There’s a very attractive idea, particularly for drug-coated balloon users. Drug-coated balloon users are a very rapidly growing segment of the marketplace. This is kind of a modern day take on vessel repair following angioplasty.

Scott Nelson: Got it, and the idea for this ability to tack a dissected portion of the artery, that early idea came from an experience that Dr. Schneider had during a Christmas break, correct? Years back?

Bruce Shook: That is true, and it’s a funny story. Peter was hanging Christmas lights on his house with a staple gun and it occurred to him that he routinely encountered the same type of a problem inside arteries when he was in the Cath Lab performing angioplasty, and he wondered, “Why couldn’t I just tack up these dissections or these flaps that get created by the angioplasty balloons instead of stenting the entire lesion?” Which was commonplace practice, still is today. This is the so-called full metal jacket approach, and it’s overkill in many situations. He came up with this minimal metal solution to the problem, and we literally called the devices, as I said, “tacks” today.

Scott Nelson: Such a great story, especially considering where you’re at in the life cycle of the product. Give us an idea of where Intact Vascular is regarding clinical data and regulatory approval process.

Bruce Shook: Well we’ve completed three OUS trials, there was a first-in-human trial that Dr. Schneider completed in Paraguay, a small initial study. Then we completed TOBA, which is just shorthand for Tack Optimized Ballon Angioplasty. Completed that trial, which was our first large-scale above the knee trial in Europe, 138 patients, and the results were recently published in the Journal of Vascular Surgery.

Then we’ve also completed a TOBA BTK, shorthand for below-the-knee, which is our first trial in that segment of a population, 35 patients, and the 12-month data were recently presented at SCAI, which is a major cardiology conference. We have CE Mark for our above-the-knee system, we will soon have CE mark for our below-the-knee system and then regarding what’s happening now, we’re nearing completion of a very large pivotal trial called TOBA2 for our above-the-knee indication.

I expect we’ll complete enrollment toward the end of Q1 and that will be followed with a PMA submission once we have 12-month data. We are set to begin enrollment in our pivotal below the knee trial, TOBA2 BTK, we should commence enrollment in that trial in Q1 as well.

Scott Nelson: I’m acutely familiar with the peripheral vascular space, that’s where I’ve spent most of my time in medtech, but for those listening that want to get a better understanding, there are limited below-the-knee treatment options for arteries that are diseased below the knee limited treatment options. So in looking at the animations that you guys have on your website and learning a little bit more about your technology, it seems like that it woul,d be pretty easy to generate interest from a lot of interventional cardiologists and vascular surgeons for below-the-knee applications.

Bruce Shook: Absolutely. You correctly point out that there are very few approved tools to treat that disease and in fact, there are no approved stents in the US to treat below-the-knee disease, and this is the very first large multi-site pivotal trial that FDA has ever approved for a vascular implant below the knee.

So I think we are well positioned to bring the very first vascular implant to the market for this disease, so it’s very exciting.

Scott Nelson: I don’t think I fully realized the full scope of those trials, both above-the-knee and then below-the-knee trials. One last question about those trials, regarding the structure, are you comparing to drug coated balloons? Or help me understand the involvement with DCB’s because I do recall reading something about that aspect of your clinical trials.

Bruce Shook: Yeah, we’re not comparing to DCB’s in a contemporaneous way. These are not randomized trials. The tradition with stents in the legs is that they’re typically single arm trials and the comparator is an objective performance goal that’s derived from the literature. We are using our technology as an adjunct to drug coated balloon angioplasty, at least above the knee.

For example, in our TOBA2 trial, there are two groups in that trial. In one group, we’re using our product to improve the results of plain balloon angioplasty, and in the other group we’re using it to improve the results of drug-coated balloon angioplasty, and in each case, we’re comparing to a relevant comparator.

Below the knee, we can’t use a drug-coated balloon because there are no drug-coated balloons that are FDA-approved. We’re really, at this point anyway, forced to use plain balloons below the knee.

Scott Nelson: That makes sense. Let’s take a pause there; we’ll circle back around to Intact Vascular and learn a little bit about the progress that you’ve made since joining in mid-2014. But let’s use this opportunity to rewind the clock and go back in time and understand your career a little bit better. I want to ask you a few questions about Abiomed, and then we’ll quickly transition to Neuron Therapeutics and then the eventual formation of Neuronetics. But talk to us a little bit about your experience at Abiomed.

You spent ten years there, eventually became president of the company. I think most people that are listening are probably familiar with Abiomed as it is today. I guess the first question would be, why did you make a move from Cordis to Abiomed?

Bruce Shook: Well, this goes back in time, but when I worked for Cordis, it was first and foremost a pacemaker company, it was the number two pacemaker company in the world, and it was the dominant part of the business.

The division I worked for, the implantable products division, ran into some very significant recall issues. It kind of collapsed the business; the division got sold, and the acquiring entity started to dismember it. The writing was on the wall concerning it being time to move on.

Along the way, I had become very excited about the idea getting into the startup world. Medical device startups were blossoming at that point in time. The opportunity came my way to join this little company in Danvers, Mass, called Abiomed. They had this ventricular assist device, and it had not been used in humans at that point, and they needed somebody to create a clinical research group and interact with the FDA. So they hired me to do that, that’s where I started, I was one of the very early employees at Abiomed.

Scott Nelson: You eventually, I think going back to — you were there about ten years, I believe that you ended up leaving in ’97 if my research is correct. You eventually rose up and became president of that company. Before we move on to your next move after that, do you recall a few specific challenges that you had to overcome and maybe what that meant to you either professionally or personally?

Bruce Shook: Sure. I mean, there were lots of challenges along the way. We were doing groundbreaking work in those days at Abiomed, the ventricular assist devices were kind of like scientific toys, they were not products at that point in time, nothing was FDA approved, nor had anything been through the kind of rigorous multi-site clinical trials that we would all expect today.

We blazed that trail for the VAD world at Abiomed; we did a lot of things for the first time. And anytime you’re bringing a truly first of a kind technology through the FDA approval process, there’s going to be lots of twists and turns. And that experience really taught me how to navigate that process, how to effectively interact with an agency that is naturally apprehensive about this new thing and how to survive the inevitable surprises.

Then the other thing we did for the first time as a company was to build a sales and marketing team from scratch. We had to transition that company from being an entirely R&D based organization to one that needed to market a very new and complicated product. Those transitions are tough; I learned a great deal from that experience.

Scott Nelson: That is interesting that you mentioned that. I have in my head this company was primarily built on innovative technology, and you finally get to a point where you need to start selling it and commercializing it. I bet that would be a pretty major shift in the lifecycle for any company.

Bruce Shook: It’s a huge psychological change for the company because literally over the span of maybe six, nine months you go from an organization that is completely dominated by technical people to an organization where a third of your employees might be sales and marketing staff, right? That’s a pretty wrenching change for people to go through.

Scott Nelson: After your time at Abiomed, you spent about four years at Neuron Therapeutics. But before we got here, I noticed that you ended up getting your MBA from MIT in the late 90’s, it was probably around the time that you ended up leaving Abiomed. That stood out to me because certainly at that point in your career, you had a B.S. in chemical engineering from Penn State, a Masters in Bioengineering from Columbia, obviously very good schools, you had a ton of business experience.

I have to think there’s a lot of people in the audience listening to this that are thinking, “Should I go back and get my MBA? I’ve got ten years of experience, is it worth it?”  So I wanted to get your take on that before we move on to Neuron Therapeutics and Neuronetics.

Bruce Shook: Sure, you know, at the time, I felt that I had risen to a position at Abiomed that I hadn’t been fully trained for. I had no training in finance, whatsoever. Nor did I know anything about raising money. Abiomed had gone public in the late 80’s which was something that the then-CEO had handled.

I wasn’t involved with that, and we lived off of those IPO funds. So there was no need to raise money. I thought that corporate finance was an area where I had to deepen my knowledge if I was going to lead my own startups, which is something that I was very focused on doing at that point in my career. I was very anxious to run my own show.

You know, Sloan was just a great fit for what I needed, and it’s an amazing place, I ended up learning much more that I expected. It also was a springboard, allowed me to work my way into the startup world. I started my first company right after graduating, which was Neuron Therapeutics.

Scott Nelson: Let’s use this as an opportunity to talk about Neuron Therapeutics. First, maybe address that the problem that you were trying to solve and then I want to ask a follow-up question about the clinical trial failure that you experienced, and what you did in response to that.

Bruce Shook: I started Neuron Therapeutics with some neuroscientists from Thomas Jefferson University in Philly, and we were working on an entirely new approach to treating ischemic and hemorrhagic stroke. We developed a synthetic form of cerebral spinal fluid that could carry enormous amounts of oxygen and could be circulated in the subarachnoid spaces around the brain. The whole idea was to oxygenate a scheming brain tissue, independent of the diseased vasculature.

We were going in the back door, so to speak. It was a very radical idea, and some great animal data was supporting the effectiveness of the idea. But as you correctly pointed out, we got into clinical trials, and it just didn’t work in humans.

I think we didn’t anticipate how difficult it would be to get acute stroke patients to the hospital quickly enough and we didn’t appreciate that the complexity of the procedure itself that we had created would cause vital delays. With a stroke, you can’t waste a minute. The experience taught me the importance of building technology that is simple for the user. The technology itself may be complex, but you need to make things simple for the user.

Scott Nelson: When that happened, I’m curious too and learn a little bit more about how your team responded. Because I wonder if it’s any different than a conversation I recently had with Kevin Sidow, who is the CEO of Moximed. They went through a period with their device where an FDA panel gave them a thumbs-down.

It almost forced them to become a little bit smarter and a little bit leaner, and it forced them into profitability and led them to kind of iterate and pivot. Obviously, it wasn’t good news; it wasn’t the news anyone wanted to hear at that point, but it did allow them to shed some weight, and then springboarded them into a better position moving forward.

How did you and your team deal with this news?

Bruce Shook: We had IDE approval to do this study. It was a relatively small study, it was a pilot study, and it was us looking at the data, looking at the results, and we concluded that it just did not work the way we thought it would. We didn’t believe that there was anything that we could do to make it work the way it needed to work.

That was a decision that our team made in conjunction with the board of course and we ended up selling the IP off, and that was that. Much of the team stuck together, and we all went on to form Neuronetics about nine months later.

Scott Nelson: Speaking of Neuronetics, when you look at the technology now, it’s been featured on the Daily Show, Doctor Oz, pretty well-known publications across the US if not across the world is a pretty broad utilization. But it certainly wasn’t all rosy; it certainly wasn’t easy along your journey. Your TMS device, that got a thumbs-down from the FDA advisory panel, is that right?

Bruce Shook: Yeah, it was a controversial panel meeting, let’s put it that way, yes.

Scott Nelson: Talk to us a little bit about that. I think that panel meeting was early 2007 right?

Bruce Shook: Yeah, sounds about right.

Scott Nelson: So mid-2007, and so here you are with this technology, and the FDA gives you the thumbs down for something that you strongly feel is working and is proven. So walk us through that time and how your team worked through that experience.

Bruce Shook: Right. Well, first of all, we were thoroughly convinced we had something that worked. It is true; we missed our primary end point by a minuscule amount, I think seven one thousandth of P value point. It was a trivial miss on the primary end point, and we had multiple secondary measures of efficacy that were very positive and when you add to that, the fact that the safety profile of the NeuroStar Technology is far superior to drug therapy.

It seemed ridiculous to us to not have this therapy out there and available to the appropriate patients. The treatment options at the time for depression were limited to just drugs and shock therapy, and we clearly thought we had something unique to add to that mix. So we worked with FDA relentlessly, and we did dozens of analysis demonstrating the effectiveness of the treatment. We brought some of the most accomplished people in psychiatry into the discussion who were very supportive.

We ultimately refiled the application after the panel meeting as a De Novo 510(k) application, something that the FDA wanted us to do. And ultimately, the FDA decided to reconvene some of their psychiatric experts to look at the data and some of the analytical work that we had done and that was enough to win the day and move us to clearance.

Scott Nelson: So looking back at that experience, would you do anything differently? Let’s say you had a hypothetical company and ran into that same scenario where the FDA or a regulatory body was being overly difficult, what advice would you give the other founders that are in the same scenario?

Bruce Shook: Well. I think the first bit of advice I would give anybody is that civility matters no matter how difficult the discussion may get. There is absolutely no point in getting angry and getting emotional about it. The discussion should be based on the scientific facts, and you need to focus it on the scientific facts. I also think that bringing incredible, skilled, and knowledgeable clinicians who are in no way conflicted into the discussion is very, very helpful.

I think you just need to understand the real source of whatever the agency is uncomfortable about. They’re smart people, and they have a job to do just like all of us do and typically, if you can marshal data- based arguments that make sense and they’re valid, you can convince people. So I think you keep it focused on the data and the risk-benefit profile of the technology and you do the best you can to make your case.

Scott Nelson: I love your response on not getting emotional about any decision that comes down. I think it’s easier said than done, but a good reminder for anyone in a similar scenario. At the end of the day, to your point, civility and the science will win. Maybe with a little bit of persistence, the science and the data will hopefully win the day, but good point nonetheless.

I want to quickly hone in on the coverage and reimbursement aspect to Neuronetics and what you accomplished there because, as I mentioned earlier, it seems like there’s some better insurance coverage on TMS therapy now – and that obviously wasn’t always the case. So can you talk to us a little bit more about your approach to not only gaining coverage but also getting reimbursement for that particular therapy?

Bruce Shook: Reimbursement was, I think, one of the toughest obstacles that we had to overcome. Neuronetics is now at full, or very near full, reimbursement of the technology, but it took six or seven years of really hard work to get there. We had to secure new CPT 1 codes, which is a very challenging and political process. We had to work with every insurer in the land to secure coverage policies and then once you have policies in place, you have to frequently do battle over the payment amount.

So I would say that reimbursement for first of a kind technology is a substantially higher hurdle than FDA approval partly because you have to deal with so many players simultaneously. So if I were to give advice to other people, I think we all have to be extremely thoughtful about the reimbursement hurdles that any new technology presents as part of your upfront diligence process. For example, a technology that demands new CPT 1 codes is going to consume much more time and money than one that can leverage existing codes.

So if you do go down that road, you have to be willing and able to invest in a broad clinical development program, something that is going to generate compelling randomized data and you have to have the right people working reimbursement for you. It is a skilled position, and I give a great deal of credit for the reimbursement success at Neuronetics, to Mary Hailey who ran our reimbursement team. She did an extraordinary job.

Scott Nelson: Yeah. With so many stakeholders being involved, this question comes up again and again in the sense that coverage and reimbursement are becoming the biggest hurdle regarding the evolution of a certain medical device technology, especially when you are dealing with private payers. Because there’s so many of them and it’s just a different beast overall. So I’ve got to think that you’ve probably learned quite a bit during that process dealing with so many different private payers and the TMS Therapy.

Bruce Shook: Yeah, you can’t underestimate the difficulty of winning that war and I don’t think you can underestimate the time and money required to wage that war either.

Scott Nelson: Looking back over your ten years at Neuronetics, is there anything else that you think is worthy of mentioning or something that you look back and think, “Wow, I’m proud that we did this and didn’t go in that certain direction”?

Bruce Shook: I think that the fact that we invested so much effort and so much money in clinical development early on at Neuronetics ultimately saved us, particularly when it came to reimbursement. We ended up with two large randomized controlled trials. One that we exclusively funded as a company and then the other that NIH-funded (and we supplied the equipment). I think having those two trials allowed us to ultimately develop all the reimbursement that’s in place today. It took a long time, and it took a lot of cash, but it was money very well spent.

Scott Nelson: I think to your point earlier about even getting a CPT category one code, the level of clinical evidence that’s needed, if one has to potentially go in that direction, better to make sure that you allocate the proper budget for the clinical trials up front.

I’m curious to learn a little bit more about your transitioning out of Neuronetics. So what brought you out of there in the first place?

Bruce Shook: Yeah, I was recruited into Intact by Sherrill Neff from Quaker Partners. Sherrill’s one of Intact’s early investors and board members and was also a long time investor and board member at Neuronetics and the company is just down the road from Neuronetics.

I thought the technology was fascinating and it was a wonderful fit for what is happening in the peripheral vascular space and the team was very skilled. So the company needed leadership and cash and I was quite confident that I could acquire both of those things. It’s been a great fit.

Scott Nelson: I think at that point, Intact Vascular, the company had raised a series A back in 2012 and then you came on board about a year later. You raised a pretty hefty series B of $38 million. That was led by NEA, correct?

Bruce Shook: Right. I brought NEA and Justin Klein into the investing syndicate. They were joined by Quaker and HIG Bio Ventures, both of whom had participated in the A round.

Scott Nelson: What advice would you give to other medtech entrepreneurs out there who are at a stage where they’ve raised maybe some angel money and maybe earlier on they raised some friends and family rounds, but are ready for that next step? Whether they need to raise a larger syndicate through angels or they need traditional venture capital money, do you have any best practices or what’s your general thought process on that?

Bruce Shook: Yeah, I can offer a few thoughts. One is that you need a very clear message on everything from the market and the customers you’re going to serve to the clinical trials you plan to run to projected COGS to health economics and everything in between. You can’t cut corners on preparation before you’re in front of investors that matter and if you need to, find the experts who can help you in areas where you’re not strong. Nobody knows everything, so I think you need to supplement yourself with people that have, the necessary expertise – like health economics for example.

The second thing that I would suggest is that you test drive what you’re going to present with people who are not going to invest but can and will be critical of you. You want to present to people who can rough you up before you’re ever in front of a prospective investor that really matters. I found that to be very, very helpful in refining the pitch and figuring out where the soft spots are. Another thing I think that’s really helpful is if you can find warm introductions to investors, you are much, much more likely to get an audience with that investor than if you’re trying to go in cold – articularly if you’re relatively new to the money-raising game and people don’t really know you well.

Then lastly, this is a mistake I’ve seen other people make a lot. You have to minimize the amount of time that you’re talking. If you have 60 minutes with an investor, you ought to be able to tell your story in 20 minutes. Now, they’re going to ask questions, and you’re going to fill that hour, but I think people sometimes are so anxious to tell their stories in all their glory that they go on for the full hour and I think that’s a very big mistake. You have to hone the pitch such that it’s concise and fits in roughly the 20 minute time span.

Scott Nelson: Four solid points that would be valuable for anyone listening that’s in the similar situation and especially with respect to your point about actively seeking out those experts to help you craft a certain story. I had a conversation earlier this week with Dr. Bob Smouse who’s a practicing interventional radiologist but is one of the founders of Brightwater Medical, and it’s a therapy that’s close to home for him. But he actively sought out other people that had the domain expertise that he clearly didn’t have, which I completely respect. It’s one of those things that is probably a little bit easier said than done especially if you’re knee-deep with the device, in the business, etc.

Bruce Shook: Yeah, you have to give them a multifaceted story. Get all the help you can with each facet.

Scott Nelson: As we look to wrap up this conversation, in regards to your clinical trial, you expect to submit your PMA to FDA in Q1 of 2017, is that right?

Bruce Shook: Well, we are already in the midst of the PMA submission process. We’re following a modular approach, but the real trigger for the final submission to FDA will be 12-month data, which we would get in early ’18.

Scott Nelson: What’s next for Intact Vascular, outside of the clinical data – can you speak to that?

Bruce Shook: The next big milestone for us will be the startup of TOBA2 BTK, the pivotal below-the-knee trial that we talked about earlier and we’ll be enrolling that trial for roughly the next 24 months. So that really will take us out into 2019 between the pivotal below-the-knee trial enrollment and the completion of our above-the-knee pivotal trial and submission of our PMA.

Scott Nelson: With respect to Intact Vascular, you’ve been there since mid-2014, about two and a half years now. Looking back over that time, is there anything else that you think will be valuable for the audience to know and understand?

Bruce Shook: I think we have a unique opportunity here at Intact. We are bringing a very differentiated technology to a very well established market with our above-the-knee offering, and we’re a first mover in a nascent market with our below-the-knee offering. So in many ways, it’s the best of all worlds. I think it’s a unique opportunity.

Scott Nelson: We’ll end our discussion with the last three rapid-fire questions. They’re rapid-fire questions, but they don’t necessarily have to be rapid-fire answers. So feel free to expand a little bit. So Bruce, what’s your favorite business book?

Bruce Shook: That’s a very tough question. I think if I had to pick one, I would pick Crossing the Chasm by Jeffrey Moore. I think it’s a seminal work on the topic of new technology adoption. I would say it’s a must-read for any entrepreneur who’s interested in bringing truly new products to the market and I read it very early in my career and found it fascinating. It taught me how to think differently about new product introduction.

Scott Nelson: Question number two, is there a CEO that you’re following right now or maybe one that’s inspired you in the past?

Bruce Shook: I’ve been impressed with what Scott Drake has done at Spectranetics. He and Shar Matin, their COO, I think they’ve done a phenomenal job with that company. They turned around a difficult situation, and they made a very smart acquisition with their purchase of the Stellarex drug-coated balloon technology from Covidien. So that’s definitely a company to watch. I think they’ve done some really great work there.

Scott Nelson:So the last question, Bruce, if you had the chance to jump in a time machine and rewind the clock, what would you tell your 30-year-old self?

Bruce Shook: Oh, I think I’d probably say, “Sell everything you own and buy that Apple stock the first time you saw the Apple computer.” I wish I’ve done that. Beyond that, I guess I would tell myself that you have more influence than you appreciate and you should use it.

Scott Nelson: Great way to end the discussion. Thanks again for your willingness to spend some time with us.

Bruce Shook: Oh sure, I enjoyed it.

 

Read more Medsider interviews on MassDevice here.

The post 4 Key Insights When Raising Money for Your Medtech Startup: Interview with Bruce Shook, CEO of Intact Vascular appeared first on MassDevice.



from MassDevice http://ift.tt/2mx2VRe