BionX adds $11.4m for powered ankle prosthetic

BionX said it added $11.4 million to the $6 million it drummed up last year for its Biom powered ankle prosthesis.

BionX, previously known as BiOM (which was formerly known as iWalk), said in a regulatory filing that the new backing comes from a quartet of investors from outside the U.S.

Almost exactly 1 year ago, the Bedford, Mass.-based company said it hoped to raise a total of $10 million.

BionX touts the Biom prosthesis as the only commercially available mechatronic ankle with “powered propulsion.” It’s designed to use computer processors to adjust the ankle’s stiffness and propulsive torque to emulate natural muscle function. The company was founded by MIT robotics guru Hugh Herr.

Earlier this month, BionX inked a deal with Otto Bock Healthcare to exclusively distribute the Biom ankle in Germany, Austria, Switzerland and Scandinavia.

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Seno Medical touts data from Imagio breast cancer pilot study

Seno Medical Instruments on Monday released data from the pilot study portion of its Pioneer pivotal study examining its Imagio opto-acoustic tool designed to diagnose breast cancer.

The company said data from the trial showed Imagio system improved physicians’ ability to classify benign breast masses when compared to traditional ultrasounds methods. Data from the 100-patient pilot study was presented at the Radiological Society of North America’s annual meeting in Chicago earlier this month.

“Downgrading benign masses classified as BR 4b (moderate suspicion), 4a (low suspicion) and 3 without missing cancers is an unmet need that the Imagio OA breast imaging system can potentially help address. If these pilot findings are verified after the completion of the multicenter Pioneer Study, we will have confirmation that the Imagio OA breast imaging system could help women not only avoid biopsy procedures but also multiple short interval follow-up ultrasound exams over 2 years,” co-principal investigator Dr. Erin Neuschler of Northwestern University’s Feinberg School of Medicine said in a press release.

In the pilot study, independent specialists assessed 102 masses using the Imagio OA images, and were able to downgrade conventional diagnostic ultrasound findings of BR3 masses to BR2 masses in 33% of cases, BR4a masses to BR2 or 3 masses in 53% of cases and BR 4b masses to BR 3 or 2 masses in 33% of cases.

The initial pilot study is only part of a larger study slated to enroll over 2,000 subjects at multiple centers, Seno Medical said. The study aims to examine the ability of the Imagio system to downgrade Breast Imaging-Reporting and Data System scores, according to the company.

“Diagnostic specificity remains disappointingly low for diagnostic morphologic imaging modalities and reading algorithms that have been optimized to achieve very high sensitivity at the expense of low specificity – which, of course, results in many false positives and generates a high percentage of negative biopsies. These encouraging results indicate that Imagio can potentially offer physicians a tool to more accurately identify women who do not have breast cancer, and thus, who do not need to undergo invasive and expensive biopsy procedures and/or the stress of undergoing multiple follow-up exams over a 2 year period, depending upon whether the OA-based downgrade is to BI-RADS category 2 or 3. Reducing false positives and the number of negative biopsies, 2 of the main perceived and well-publicized ‘harms’ of breast cancer screening, may help defuse some of the criticisms being put forth by the anti-breast cancer screening movement. As breast radiologists, we can and we should do better in diminishing false positives and reducing negative biopsies. OA is a functional and morphologic diagnostic tool that has the potential to help us achieve better specificity without sacrificing sensitivity, diminish the percentage of negative biopsies generated by breast cancer screening, and to reduce the perceived ‘harms’ of breast cancer screening,” Seno medical director Dr. Thomas Stavros said in prepared remarks.

The Imagio system combines traditional ultrasound with light-based imaging, providing physicians with a closer look at “suspicious” breast masses without subjecting patients to radiation, injectable contrast agents or invasive biopsies.

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MassDevice.com +3 | The top 3 medtech stories for December 23, 2015

Say hello to MassDevice +3, a bite-sized view of the top three medtech stories of the day. This feature of MassDevice.com’s coverage highlights our 3 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.

 

3. OrbiMed launches $950m healthcare fund

OrbiMed said it closed another venture capital fund worth $950 million that it plans to deploy on about 30 companies in the medical device, biopharmaceutical, diagnostics and healthcare IT markets.

The New York-based VC giant said its OrbiMed Private Investments VI fund will put up investments ranging from $10 million to $75 million. Last year OrbiMed floated a $924 million fund it planned to use in $20 million to $150 million increments for acquiring healthcare royalty streams. Back in the fall of 2013 OrbiMed launched a $735 million healthcare fund. Read more

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2. Intuitive Surgical puts another $9 million into Luna Innovations’ shape-sensing tech

Luna Innovations said that Intuitive Surgical agreed to put up another $9 million for the shape-sensing technology it bought for its da Vinci robot-assisted surgery platform.

Pleasanton, Calif.-based Intuitive paid a total of $12 million last year for the technology, which is designed to provide real-time measurements to help surgeons sense positions and track locations in the body during surgery. The latest installment closes out the deal, which once included milestones worth another $18 million. Read more

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1. CryoLife in $130m deal to enter valve market with On-X Life Technologies buy

CryoLife Inc. made a big play for the mechanical heart valve space with a $130 million deal to buy On-X Life Technologies.

On-X makes an aortic valve replacement and is developing a mitral chord repair device called Chord-X. The Austin, Texas-based company put up sales of about $33 million last year, CryoLife said. Read more

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CytoSorbents scraps EAP path, pursues IDE and PMA for CytoSorb

CytoSorbents (OTC:CTSO) said today it’s dropping its pursuit of the FDA’s fast-track Expedited Access Pathway for its CytoSorb for treating sepsis.

The decision came after meeting with the FDA’sCenter for Devices and Radiological Health and Center for Drug Evaluation and Research in which the company came to the conclusion that “there would be no significant time or cost advantage associated with pursuing the EAP designation for CytoSorb for the treatment of sepsis.”

CytoSorbents said based on that data, it decided to scrap plans to pursue the EAP and instead pursue an investigative device exemption and premarket approval for the device.

“Based upon the criteria of the EAP program, we believed that it was possible to obtain EAP designation for CytoSorb and pursue a registration trial using surrogate endpoints, rather than 28-day all-cause mortality – an endpoint that no sepsis treatment has been able to achieve in pivotal trials – for early market approval.  We are obviously disappointed that this was not the case,” CEO Dr. Phillip Chan said in a press release.

The Monmouth Junction, N.J.-based company said the IDE and PMA route eliminated the potential that it would require a post-market efficacy study, which could have been required through an EAP route.

“However, based upon our positive clinical experience and the significant international research being conducted on CytoSorb today, we continue to believe that CytoSorb blood purification is one of the most promising treatments for sepsis. Unlike previous treatment attempts by other companies, CytoSorb attacks sepsis from many different angles, such as a reduction of excessive pro-inflammatory cytokines and inflammatory mediators, a reduction in many pathogenic toxins, a stabilization of various key organ parameters such as hemodynamics, and a re-direction of the immune response to prevent cell-mediated injury of vital organs.  We strongly believe the effectiveness of this broad approach is one of the reasons CytoSorb adoption and usage in sepsis continues to grow,” Chan said in prepared remarks.

CytoSorbents said the FDA offered to aid the company with its sepsis clinical trial design once it has submitted a formal IDE.

“CytoSorb has been credited with successfully saving the lives of many patients all over the world.  We remain committed to moving forward with our U.S. clinical program in sepsis under the traditional IDE pathway and appreciate the FDA’s offer to review our future plans.  In doing so, we hope to stem the tide of one of the top ten causes of death in the United States for which no approved therapy currently exists,” Chan said in a prepared statement.

CytoSorb won CE Mark approval in the European Union in 2011. The device is designed to filter inflammation-causing substances such as cytokines from the blood, the company said.

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Insightec touts reimbursement win for Exablate

Insightec said today it received positive coverage policies from Blue Cross Blue Shield licensees for its Exablate magnetic resonance imaging-guided focused ultrasound device for pain palliation treatments for bone metastases

The recent round of favorable coverage policies for the Exablate came from BCBS Louisiana, Florida Blue, Independence BCBS, Highmark BCBS and Blue Shield of California, the Israel-based company said.

“Decisions from leading insurers to cover Insightec’s treatment are a welcome recognition of the demonstrated clinical benefits for Insightec’s completely non-invasive treatment for patients suffering from pain related to their bone metastases. By formalizing favorable coverage policies, BCBS plans are providing a viable treatment option for many more patients and physicians,” CEO Kobi Vortman said in a press release.

The Exablate system uses both focused ultrasound to ablate fibroid tissue and magnetic resonance imaging to guide the ultrasound ablation to specific tissue targets, the company said.

“We are very happy that our work continues to yield  favorable decisions which will enable patients suffering from metastatic bone pain access to a non-invasive treatment that quickly reduces pain, allows return to normal activities within days and is available in leading medical centers across the U.S.. We are continuously conducting independent, post-market studies in efforts to build support for additional coverage by insurers,” reimbursement veep Dee Kolanek said in prepared remarks.

In October, Insightec said it won expanded FDA premarket approval for its next generation Exablate system used to treat symptomatic uterine fibroids for patients who wish to retain their uterus and fertility.

The approval was based upon documented clinical data from 118 patients who became pregnant after receiving treatment with the Exablate device, Insightec said.

The Exablate system was 1st approved by the FDA in 2009. The expansion and approval of the next generation machine was the second labeling adjustment since initial approval, the company said.

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Private Equity firm EQT buys Lima

Lima Corporate said today private equity firm EQT acquired it through the purchase of the majority of the company’s shares, shifting ownership from Ardian.

The transaction is still subject to regulatory approval in European jurisdictions, the company said.

“EQT has followed Lima for almost ten years and we are impressed by the Company’s growth history as well as the strength of the management team. We are now keen to support Lima in its next phase of development. Lima is well-positioned for future growth and we are convinced it can be accelerated by leveraging our industrial network and resources. We look forward to working with the management team to achieve the full potential of Lima,” EQT partner Michael Bauer said in a press release.

“I have to thank all the people that have believed in Lima Corporate, from our board to our shareholders to our surgeons and our employees.  By working together, we are confident to continue to provide surgeons and their patients the most effective and safest implant technology on the market today,” Lima CEO Luigi Ferrari said in prepared remarks.

Earlier this month, Lima said it closed its purchase of Zimmer Biomet‘s (NYSE:ZBH) unicompartmental high flex knee and discovery elbow systems in the Japanese market, as well as the Japanese supply chain.

The deal closed after receiving approval from the Japanese Fair Trade Commission, Italian Lima said.

In July, Lima said it completed its acquisition of knee and elbow assets from Zimmer Biomet.

The Italian orthopedic company said it purchased Zimmer’s unicompartmental High Flex knee implant and Biomet’s Discovery elbow system within the European Economic Area and Switzerland. Lima Corporate also acquired Biomet’s Vanguard complete knee system in Denmark and Sweden.

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Titan Medical closes in on 1st-in-human for Sport surgical robot

Titan Medical (CVE:TMD) said this week that initial versions of its Sport robot-assisted surgery platform are ready for engineering verification ahead of 1st-in-human trials early next year.

The initial Sport versions to include both work station and patient cart are “precursors” for the systems to be built for the trials next year, Toronto-based Titan said.

“This fully integrated initial EV system represents the efforts of many people at Titan, our surgeon advisory board and our development contractors. This is a major accomplishment for Titan as we move toward our 1st-in-human trials,” clinical & regulatory affairs executive vice president Dennis Fowler said in prepared remarks.

“I am very pleased and excited that we are able to finish off the year with such a positive accomplishment. I would encourage readers to visit our web site at http://ift.tt/1jp369H where we have posted pictures of this complete initial Sport surgical system,” added chairman & CEO John Hargrove.

It’s been a busy season for Titan, which last week licensed “know-how and certain technology” from Mayo Clinic for the Sport device. In November the company inked an instrument development deal with Cadence Device, raised $4 million and $8.6 million in separate rounds, and signed a private placement deal with a subsidiary of Chinese medical device distributor Ningbo Long Hengtai International Trade Co. that could wind up being worth more than $24 million.

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