Unfazed by Brexit, PureTech launches Sonde voice diagnostics firm

Life sciences incubator PureTech Health (LON:PRTC), unfazed by the worldwide impact of the U.K.’s vote to leave the European Union, announced its latest venture today: Sonde Health, which aims to use a voice-based technology to diagnose mental and physical ailments.

Based on technology licensed from the Mass. Institute of Technology’s Lincoln Laboratory, Sonde’s device is designed to analyze short vocal samples to screen for conditions based on acoustic changes.

“Sonde is developing the technology platform to extract clinically meaningful health information from everyday voice interactions people have on a range of devices they already own,” co-founder & COO Jim Harper said in prepared remarks. “The analysis does not require the content of the speech to be retained, and can readily support the strong security and privacy features users demand with regard to potentially sensitive health information.”

“The ability to help recognize early signs of psychiatric illness and monitor treatment responses on devices that people already own is an important step in moving from reactive to preventive care,” added MedStar Georgetown University Hospital’s Aimee Danielson. “This would be particularly useful in conditions that are chronically under-diagnosed, like perinatal mood and anxiety disorders, including postpartum depression, and in other mental health and central nervous system disorders where there is a lack of objective and reliable screening and monitoring technologies.”

The MIT technology uses a computer to evaluate non-linguistic vocal characteristics such as changes in pitch and harmonics, articulation timing and hoarseness or breathiness. The analysis is then used to create “vocal biomarkers” that could indicate changes in a patient’s health; that means that strong privacy and security protections can be built into the system, Sonde said.

PureTech, which raised $171 million last year in its initial public offering on the London Stock Exchange, is 1 of the few British companies whose share price rose after the Brexit vote. PRTC shares were up 5.7% to £1.53 apiece today in late-day trading in The City.

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Swedish Handicare acquires mobility device developer Prism Medical

Prism Medical said today that mobility and technical aid developer Handicare agreed to acquire it for approximately $62 million.

Swedish Handicare, which supplies technical aids for the elderly and physically disabled, will pay $12.50 for each outstanding share of Prism Medical.

“The knowledge of our employees applied with passion to solve the moving and handling problems of the mobility disadvantaged and their caregivers in all health environments, has made Prism Medical a leader in its field. Handicare has a similar values profile, has recognized what our team has accomplished, and should add value for all stakeholders as the 2 companies combine their market leading products and service capabilities,” Prism Medical chair Andrew McIntyre said in a press release.

Prism Medical said the acquisition is subject to shareholder and court approvals. Canaccord Genuity Corp is acting as financial advisor to Prism Medical during the sale, the company said.

“Through this acquisition Handicare will be able to access greater opportunities in the North American market. In addition, the combined product portfolio will be among the best in the industry and serve as a good platform for further growth,” Handicare chair Johan Ek said in a prepared statement.

Earlier this month, Prism Medical said its chief financial officer Rose Papastamos is stepping down. The company said it is currently in “advanced negotiations” with a qualified candidate for the position, and expects to finalize the hire this month.

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Medtronic launches Beacon HF monitoring service

Medtronic (NYSE:MDT) said today it launched its Beacon heart failure management service in the U.S., designed to monitor data from cardiac pacing devices to improve early interventions before heart failure events.

The service, which integrates data from the company’s implantable cardioverter defibrillator and cardiac resynchronization therapy devices, will allow patients to engage in daily health checks to both educate patients about conditions and to collect symptoms and biometrics.

“Beacon is a significant advance in our heart failure management arsenal. With its combination of valuable device diagnostics, day-to-day patient status and symptoms, and expert oversight of a trained care manager, Beacon allows clinicians to better identify, evaluate, and potentially intervene with their high-risk heart failure patients,” Dr. Jawwad Yusuf of The Stern Cardiovascular Foundation said in a prepared statement.

Care managers from Fridley, Minn.-based Medtronic will evaluate incoming data and monitor for increasing risks of heart failure to alert providers appropriately, and will provide monthly reports to physicians summarizing the patient’s health information.

“Healthcare systems are under increasing pressure to improve patient care while also driving down associated cost. MCMS is committed to helping our customers deliver better patient outcomes while addressing these challenges. Our technologies – and the data and insights they generate – put us in a unique position to help our customers enhance their patient care. With its combination of implanted device diagnostics, daily monitoring, and qualified expertise, Beacon is just one way Medtronic is innovating to provide clinically-meaningful services to hospitals, physicians, patients, and payers,” Medtronic care management services GM Sheri Dodd

Yesterday, Medtronic said it agreed to put up $1.1 billion for implantable cardiac pump maker HeartWare International(NSDQ:HTWR).

The $58-per-share deal, which represents a 93.4% premium over HeartWare’s $29.98 closing price June 24, is slated to close by Oct. 28 (the end of Medtronic’s fiscal 2nd quarter). HeartWare’s 30-day closing average as of June 24 was $30.20 per share.

The deal clears the field of the 2 major cardiac assist device makers, after Medtronic’s cross-town rival, St. Jude Medical (NYSE:STJ), paid $3 billion for Thoratec in October 2015.

HeartWare’s implantable left ventricular assist devices are designed for end-stage heart failure patients, either as a destination therapy until death or as a bridge to heart transplantation.

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Wright Medical wants retrial in Conserve hip implant loss

Wright Medical (NSDQ:WMGI) wants a federal appeals court to overturn the verdict in the 1st bellwether trial over its Conserve metal-on-metal hip implant, arguing that a new trial is warranted because the jury had 2 bites at the apple.

An Atlanta jury last year awarded plaintiff Robyn Christiansen $1 million in compensatory damages and another $10 million in punitive damages. The jury found Nov. 24 that the Conserve device was defective and that Wright failed to adequately warn patients about its risks.

The 2-week trial was the 1st for the hundreds of product liability lawsuits filed over the Conserve implant that have been consolidated before Judge William Duffey Jr. of the U.S. District Court for Northern Georgia. The jury, which deliberated for 3 days, initially found that the device was not defectively designed and was not defective when it was sold for implantation in Christiansen. But Duffey sent the jury back into deliberation, believing that the finding of no design defect was inconsistent with the jury’s answers to questions that followed, according to court documents.

Wright filed a motion for judgment as a matter of law, arguing that Duffey was wrong to re-submit the case to the jury after the 1st verdict came down. Although the judge cut the punitive damages award from $10 million to $1 million, he denied Wright’s bid for a new trial.

Yesterday Wright asked the U.S. Court of Appeals for the 11th Circuit to vacate the verdict, claiming that the 1st verdict – that the Conserve device was not defectively designed – should have ended the case.

“Wright Medical is entitled to judgment in its favor or, at the very least, a new trial based on the district court’s handling of the verdicts. There was no inconsistency in the 1st verdict that authorized resubmission. By continuing to answer questions after finding no design defect, the jury acted contrary to law and to the instructions on the verdict form. The jury’s inexplicable changes in the 2nd verdict further reflected a deliberative process that had gone off the rails. Particularly in the context of the first bellwether trial in a large [multi-district litigation], the risk of prejudice to Wright Medical from the handling of the trial weighs strongly in favor of setting aside the judgment,” Wright claimed in its appeal.

 

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Inhaled insulin company Mannkind hiring med tech sales reps to recover from failed marketing partnership with Sanofi

Mannkind chief commercial officer Michael Castagna is trying to resuscitate the inhaled insulin maker after its co-marketing agreement with Sanofi (NYSE:SNY) was cancelled at the beginning of the year due to disappointing sales. He’s fielding a team of about 70 people to sell the company’s Afrezza insulin inhaler, with about ⅓ coming from the medical device industry.

“We are looking to build a high energy nimble company that reflects the speed of the medical device industry, articulation of the science from biotech and a relentless focus on helping patients suffering from diabetes,” Castagna told Fortune.

But at Mannkind, time is running out. The company owes Sanofi $68.8 million and had $27.7 million in cash on hand as of May, down from $59.1 million to start the year.

The company also faces some challenges with their product, including the need for spirometry and titration, 2 tasks that make prescribing and administering the combination product less convenient than standard injectable competitors in the fast-acting segment of the market.

“We know about ⅓ of our targets already have a spirometry machine in the office. Another ⅓ have a referral source, and our research indicates a device at a price point of about $400 to $750 is something most physician practices will buy,” Castagna said.

The company plans to offer Afrezza with a new titration pack of 180 insulin cartridges instead of 90, in order to help patients adjust their dose during the titration period, he said.

Another issue facing the recovering Afrezza business is pricing.

“In spite of a 35% price increase in injected meal-time insulin in the last 24 months since Afrezza was reviewed by the FDA, Afrezza has had 0 price increases during that time, yet we still get accused of being too expensive,” the executive said, conceding that “people perceive Afrezza to be more expensive than currently marketed injected mealtime insulin.”

Castagna believes Afrezza is well positioned due to the growing use of continuous glucose monitors made by Dexcom Inc. (NSDQ:DXCM) and others.

“When Afrezza got approved there were about 60,000-70,000 patients using a CGM and today there are over 150,000 people with diabetes in the U.S. using these types of products. Overtime CGMs will become the standard of care where people will want to manage their glucose in real time to keep their sugars in a tight range without constant highs and lows. MannKind believes our brand will be critical in one’s ability to do this,” he said.

The company did not report any revenue during the 1st quarter as it transitions to the new, go-it-alone sales strategy. Inhaled insulin has intuitive appeal, but no one has been able to make it a profitable venture so far, in part because it is a big departure from the standard method of delivery, offered by direct competitors from Novo Nordisk (NovoLog) and Eli Lilly (NYSE:LLY) (Humalog).

Mannkind, founded by illustrious and recently deceased med tech entrepreneur Alfred Mann, has been dogged by Pfizer‘s (NYSE:PFE) infamous inhaled insulin flop, which the company pulled off the shelves in 2007, recording a pretax charge of $2.8 billion. Its Exubera inhaled insulin med had sales of $12 million that year, short of the anticipated $2 billion.

Afrezza was approved by the FDA in 2014 with a non-inferiority indication, after it was rejected twice by the agency. The combination product has a black box warning that cautions asthma and COPD patients of the risk of acute bronchospasm following insulin administration.

Castagna said the warning is not an obstacle to success, and noted that AbbVie’s has a black box warning too. Its annual sales exceed $10 billion.

Mannkind’s stock trades for a little more than a dollar on the Nasdaq, underscoring the criticality of Castagana’s new sales strategy to the company’s future, and inhaled insulin in general.

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West-Tech Materials named as MTD Micro Molding California sales group

MTD Micro Molding, a long-time leader in medical micro-injection molding, announced the appointment of West-Tech Materials as its sales representative organization for California.

“I am very excited about our new partnership in California”, said Dennis Tully, President of MTD Micro Molding. “West-Tech Materials is an ideal partner for MTD with their vast experience in the medical device industry. The addition of their team to MTD is in line with both our dedication to service to our existing customer base, and growing MTD’s presence in the California”.

West-Tech Materials was founded by Rick Campo in 1992. Over the past 15 years, West-Tech Materials has focused on providing product and technology solutions to the medical device market in the Western United States, with a focus in California. Over the years, West-Tech Materials has become one of the leading manufacturer representatives in California within the medical device market, with the majority of manufacturers represented having been with them for over 20 years.

“The goal of West-Tech Materials is to become a valuable resource to our customers, functioning as an extension of their engineering team to provide solutions in material selection, component, and assembly design”, said Rick Campo, President and Founder of West-Tech Materials.

Campo added, “West-Tech Materials is excited to represent MTD Micro Molding in the California market. MTD’s strong presence in medical devices with micro molding technology fully compliments the broad range of products and technology that we currently offer our customer base.” Campo stated that MTD’s focus on customer service and technical innovation will allow his sales team to provide an even higher level of service to help his customers with product development, design and manufacturing. West-Tech Materials has been the go-to resource for many aspects of micro manufacturing in metals for medical device development. With the addition of the micro molding capabilities of MTD, West-Tech Materials can now offer their customers full resources in their product design.

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Important steps toward streamlining access to investigational drugs for patients in need

By: Richard A. Moscicki, M.D.

FDA is only too aware that there are many patients who have a serious or life-threatening medical condition for which there is no available FDA-approved therapy. For such patients, one option may be to obtain access to an investigational drug that has not yet been approved by FDA. To do this, a physician submits an application to the FDA requesting authorization to use the investigational drug in the treatment of their patient. This is called expanded access to investigational drugs.

While FDA has been helping physicians navigate the system for many years, we are aware there have been physician and patient concerns about this process, which can be time consuming and difficult to understand. Consequently, FDA has recently made significant changes to streamline and simplify the process for single patient expanded access requests.

To make the expanded access process more efficient, we’ve just introduced a much simpler application form called the Form FDA 3926, which will be the form doctors now will typically fill out when they want to provide an investigational drug for a patient through expanded access. While the Form 1571 had 26 information fields and seven attachments, the new Form 3926 has fewer fields (11) and only one attachment. With this streamlined format, we estimate that physicians will be able to complete the form in just 45 minutes, as compared to the more difficult and time consuming effort required previously.

Also, as part of our commitment to streamlining the expanded access process, on May 16, 2016, the FDA and the Reagan-Udall Foundation held a meeting with interested stakeholders to explore additional options that might help patients and their physicians understand the process to request access to unapproved drugs. A common theme of the meeting was that navigating the expanded access process really does take a village. The physician, the drug company, FDA, and the institutional review board (IRB) all have important roles and must work together for the expanded access process to succeed.

The FDA and Reagan-Udall Foundation convened this forum to listen to the public express their needs about expanded access and to discuss ideas with stakeholders on ways that the complex process can be made more efficient and effective. Much work on the details remains, but in general there was agreement on the need for a central repository or clearinghouse where useful and relevant information could be stored in one place — a sort of “one-stop-shop” for physicians and patients to seek information about the expanded access process. As our thinking about this resource develops, we’ll keep the public informed.

For physicians seeking more information about expanded access to an investigational drug, we have developed an educational webinar to help them become familiar with the new application form. This live webinar will occur on July 12 at 1:00 PM EDT and will offer one hour of Continuing Education (CE) credit. The webinar will be recorded for viewing without CE credit. We also have released a guidance regarding Form FDA 3926, a guidance with Questions and Answers on expanded access, as well as a guidancedirected at industry addressing questions regarding charging for investigational drugs.

Expanded access is designed for seriously ill patients who have exhausted other options.  The last thing a patient suffering from a serious or life-threatening condition needs is red tape. For many years, FDA has dedicated staff to assist physicians and patients in navigating our system. We expect these important steps will help us continue our efforts to serve patients in need and to advance public health.

Richard A. Moscicki, M.D., is FDA’s Deputy Center Director for Science Operations, Center for Drug Evaluation and Research

 

 

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

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