Theragenics buys Eckert & Ziegler brachytherapy seed biz

Theragenics (NYSE:TGX) said today it picked up Eckert & Ziegler’s U.S. and Canadian brachytherapy seed business. Financial and other terms of the deal were not disclosed by the companies.

The transaction closed on the end of last year, and included U.S. and Candian customers and the rights to EZB’s AnchorSeed, VariStrand and other seed products, as well as the rights to the SeedLock Needle.

“This transaction continues our long-standing commitment to prostate brachytherapy and the physicians and patients who depend on it. As a leading manufacturer and supplier in this market, our focus has always been on quality and service. Theragenics has a long history of providing physicians with the tools necessary to achieve outstanding results for their patients. We welcome the EZB customers and look forward to working with their programs. This transaction enhances our capabilities and expands our product portfolio for brachytherapy. Our legacy is improving lives and curing cancer. This transaction enhances our mission,” CEO Frank Tarallo said in a prepared statement.

Theragenics said the newly acquired products will be added to the company’s existing portfolio, and it will manufacture the devices at its current facilities in Buford, Ga.

“Theragenics has been recognized as a leader in prostate brachytherapy and has been a valued partner of EZB in the United States. I am confident that Theragenics will continue the outstanding quality and service to which the EZB customers and patients they serve have grown accustomed,”EZB managing director Dr. Edgar Löffler said in a press release.

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Bioventus launches Durolane knee treatment in Taiwan

Bioventus said today it entered the Taiwanese patient care market with the launch of its Durolane single-injection joint-fluid osteoarthritis treatment.

The treatment is based around the NASHA process which produces stabilized hyaluronic acid which provides lubrication and cushioning in a normal joint.

“The combination of a leading OA solution like Durolane and Taiwan’s robust economy gives Bioventus a terrific opportunity to establish itself and grow in this market. Orthobiologic solutions from Bioventus are now available in 6 countries in the Asia Pacific region and we plan to build on this as we continue our international expansion,” CEO Tony Bihl said in a press release.

Durolane has been cleared with an indication for the treatment of mild to moderate osteoarthritis of the knee, the Durham, N.C.-based company said.

“In Taiwan, Bioventus will be working with Eulogiums, a sales and marketing leader with more than 20 years of experience in orthopaedics. The company’s market coverage, relationships with key opinion leaders, along with its keen understanding of markets and trends made it the natural choice to help us introduce Durolane to patients with knee OA,” international managing director Isabelle Levy-Unger said in prepared remarks.

“We believe that only knee OA products with superior quality can withstand in the competitive market in Taiwan and we have confidence that Durolane is the one,” Eulogiums CEO Kenny Liu said in a prepared statement.

Last month, Bioventus said it acquired BioStructures, a developer of absorbable bone grafts, for an undisclosed amount.

The deal for Newport Beach, Calif.-based BioStructures covers its entire line of products, including the Interface bioactive bonegraft and Signafuse bioactive bonegraft putty, plus its R&D pipeline; BioStructures employees will be given offers at Bioventus.

Created in a 2012 spinout worth $367 million from Smith & Nephew (FTSE:SN, NYSE:SNN), Durham, N.C.-based Bioventus sells an ultrasound system to promote bone healing and injections to alleviate knee osteoarthritis. Last fall, Bioventus acquired the OsteoAMP product line from Advanced Biologics for an undisclosed amount.

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Exactech deals dental assets to Salvin Dental Specialties

Exactech (NSDQ:EXAC) said today it sold the entirety of its dental biologics business to Salvin Dental Specialties, through its Salvin Regenerative subsidiary. Financial terms and other details of the deal were not disclosed.

Salvin Dental develops, manufactures and markets implant dentistry regenerative biomaterials and surgical instrumentation, Exactech said.

“While it has been a pleasure to provide Exactech’s biologic innovations to the dental market for more than 10 years, we have made the strategic decision to focus more exclusively on our core orthopaedic business. We have enjoyed a long-standing distribution relationship with Salvin, which gives us confidence that they will take good care of our dental customers in their pursuit of improving patient care,” Exactech spine and biologics GM Bruce Thompson said in a press release.

Exactech’s dental biologics biz includes its Oralife and Optecure dental bone graft. Optecure is designed for reconstruction and augmentation of deficient maxillary and mandibular alveolar ridges and dental intraossesous defects, according to the company.

The purchase will add depth to Salvin Dental’s product line and increase the company’s manufacturing capabilities, CEO Bob Salvin said in prepared remarks.

In October, Exactech said it launched its Opterak revision knee system and that the system has been successfully implanted in its 1st set of patients.

The revision knee system is composed of proprietary net compression molded polyethylene and is indicated for use in skeletally mature patients undergoing surgery for total knee replacements due to osteoarthritis, osteonecrosis, rheumatoid arthritis and post-traumatic degenerative problems, as well as to revise previously failed reconstructions, Exactech said.

The company hopes to see full market availability in the U.S. for the device in 2016.

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GlySens raises $20m for implantable CGM

Implantable continuous glucose monitor developer GlySens raised $20 million in a new round of equity financing, according to an SEC filing posted today.

The company is developing an implantable sensor for monitoring glucose that needs calibration no more than 2 times a month, the San Diego-based company said.

The device wirelessly communicates with an external receiver which provides constant glucose monitoring.

The company looks to bring in another $1 million before the round closes, according to an SEC filing.

Funds from the round so far come from 19 different investors, with 1 labeled as a non-accredited investor, and the company has not yet stated how it intends to use the funds.

In August, the FDA approved an extension of the company’s clinical trial of its CGM device, upping its timeline from 6 months to 1 year.

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MassDevice.com +3 | The top 3 medtech stories for January 4, 2016

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. Sectra buys Swedish imaging company RxEye

Sectra said it acquired RxEye AB and its cloud-based medical imaging platform for an undisclosed amount on Dec. 30, 2015.

The RxEye Cloud service is used to remotely view images by more than 2,000 users in European radiology, nuclear medicine and pathology departments and teleradiology services companies, Linköping, Sweden-based Sectra said. RxEye, which employs 6 workers, posted sales of about $833,000 last year (SEK 7 million), Sectra said. Read more

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2. InVivo Therapeutics wins FDA approval for pivotal trial of spinal scaffold

InVivo Therapeutics said that it won FDA approval to shift a pilot trial of its spinal scaffold to a pivotal probable benefit study.

Cambridge, Mass.-based InVivo said it expects the FDA to OK its Inspire study, designed to enroll 20 patients with spinal cord injuries, after it submits 6-month data during the 2nd quarter from 5 patients already enrolled in the pilot study. Read more

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1. Bosch gets in on $3m Series B for Emperra’s ‘smart’ diabetes system

Emperra said that it closed a Series B round worth $3.1 million for its Esysta “smart” diabetes management system.

Potsdam, Germany-based Emperra said the VC arm of the Bosch Group, Robert Bosch Venture Capital, joined existing backers Peppermint VenturePartners and Investitionsbank des Landes Brandenburg. CEO Christian Krey and CTO Dr. Janko Schildt also got in on the round, Emperra said. Read more

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Artificial pancreas from UVA heads to trials

A device developed at the University of Virginia School of Medicine which automatically monitors and regulates blood-sugar level in type 1 diabetes patients is slated to undergo 2 final clinical trials beginning early this year.

UVA said it was hopeful that the long-term clinical trials would pave the way for FDA clearance of the ‘artificial pancreas’ devices for type 1 diabetes sufferers.

“To be ultimately successful as an optimal treatment for diabetes, the artificial pancreas needs to prove its safety and efficacy in long-term pivotal trials in the patient’s natural environment. Our foremost goal is to establish a new diabetes treatment paradigm: the artificial pancreas is not a single-function device; it is an adaptable, wearable network surrounding the patient in a digital treatment ecosystem,” research team lead Boris Kovatchev of the UVA Center for Diabetes Technology said in a press release.

Trials are slated to be run at 9 locations across the U.S. and Europe, and are being supported by more than $12.6 million in grant money from the National Institute of Health’s National Institute of Diabetes and Digestive and Kidney Diseases, according to the university.

The 1st study, the International Diabetes Closed-Loop trial, is set to test UVA developed technology. The university’s technology has been ‘further refined for clinical use’ by Charlottesville, Va.-based startup TypeZero Technologies, who licensed the technologies.

A 2nd trial will examine a control algorithm developed by Dr. Francis Doyle III at Harvard to test its ability to improve control of blood-sugar levels.

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Gore touts bioabsorbable hernia mesh study data

W.L. Gore & Associates today released data from a long-term study of its Gore Bio-A tissue reinforcement bioabsorbable mesh designed to treat complex ventral hernias in patients with contaminated fields. The study was published in the Annals of Surgery.

Gore’s Bio-A is designed as a web of biocompatible synthetic polymers that are gradually reabsorbed into the body while facilitating tissue generation and healing, according to the company.

The study, which enrolled over 100 subjects, reported a lowered recurrence rate at 17% after 24 months in patients treated with the Gore Bio-A, versus a 39% recurrence rate in patients treated with a biologic mesh.

“I think this study represents an important step forward in defining the most appropriate way to reconstruct complex abdominal wall defects. Bio A performed very well in this challenging group of patients and will provide a cost-effective alternative for reconstructive surgeons,” lead investigator Dr. Michael Rosen of the Cleveland Clinic said in a press release.

Patients treated with Gore’s mesh also reported higher quality of life scores, and faced lessened long-term complications as the mesh did not have to be removed at a later date, Gore said.

“This study proves for the first time something we have believed all along: a biosynthetic mesh can be equivalent or better than a biologic. By being both more cost effective for hospitals and payors while also improving quality of life for patients, GORE BIO-A Tissue Reinforcement is truly advancing healthcare and the way we treat CVH,” general surgical products biz unit leader Ron Anderson said in prepared remarks.

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