Avita says EU sales temporarily interrupted, inks Japanese distro deal for Recell

Avita Medical

Avita Medical (ASX:AVH) said yesterday that sales of its Recell device in the European Union were temporarily interrupted due to an administrative issue with its notified body and announced a new Japanese marketing and distribution deal.

The Valencia, Calif.-based company said that the sales interruption occurred after its EU-based notified body “reported open items related to administrative and procedural non-conformities,” but said that the action has no impact outside the EU and that issues are not related to product quality, safety or performance.

Avita said that it does not actively promote the product in the region and that activity there is limited to filling purchase requests as they are received, with an average of $40,000 in sales per month.

“It is important to note that this interruption is unrelated to the performance and safety of our products and does not impact the U.S. market. We will work closely with the authorities to close this administrative request as soon as possible, and no later than the 3rd quarter of calendar 2019. We do not actively promote in the EU at this time but do want to ensure that our products are available as soon as possible to those institutions who request it and to patients who can benefit from their use,” Avita CEO Dr. Mike Perry said in a press release.

In a separate release, Avita said that it inked a Japanese marketing and distribution deal with Cosmotec, who recently filed with the country’s Pharmaceuticals and Medical Devices Act, or JPMDA, for approval of Avita’s Recell system.

Avita said that the JPMDA has accepted the application for review and that the review is expected to take nine months to one year. Financial terms of the deal with Cosmotec were not released.

“The number of patients suffering from chronic wounds and decubitus ulcers is increasing in Japan due to aging. Japan is also planning for the Tokyo Olympic Games in 2020 and must be prepared for major disasters such as a large earthquake. We are very proud to add the Recell System to our product lineup. With over 30 years since our foundation, Cosmotec has been doing business in 90-100% of high acute care hospitals in Japan in the fields of cardiac surgery, vascular surgery, and wound care. As a member of the M3 Group, we can deliver the Recell System’s benefits to at least 90% of Japanese plastic surgeons and dermatologists through the portal site ‘m3.com.’ With this opportunity, we would like to contribute to the advancement of burn injury and wound care in Japan,” Cosmotec prez Kiyoshi Takei said in a prepared statement.

“We are very excited to partner with Cosmotec on the commercialization of the Recell System in Japan, a key global market. Cosmotec’s experience marketing medical devices and other products into hospitals and surgical suites throughout Japan, including specialties requiring a high level of training such as cardiovascular treatment, make them an ideal partner for us. We are also pleased that they are backed by the M3 Group, a major healthcare company with great physician access in Japan and other markets. The filing of the JPMDA application is a major milestone, and we look forward to making the Recell System available to patients in Japan,” Perry said in a press release.

Last month, Avita Medical reported raising approximately $14.4 million in a new round of equity financing, according to an SEC filing.

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Senseonics extends distribution agreement with Roche Diabetes Care

Senseonics Holdings (NYSE-American: SENS) — maker of an implantable continuous glucose monitoring system for people with diabetes — has extended its distribution agreement with Roche Diabetes Care.

The agreement extension, announced yesterday, has Roche continuing as Senseonics’ exclusive distributor in Europe, the Middle East and Africa — excluding Scandinavia and Israel. The agreement also adds 17 countries including Brazil, Russia, India and China where Roche will have exclusive distribution.

Senseonics officials boast that the company’s Eversense device is the first CGM system with an implantable sensor that someone with diabetes can wear for up to 90 days.

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

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Orthofix acquires distributor Options Medical

OrthoFix

Orthofix (NSDQ:OFIX) said today that it acquired Florida-based medical device distributor Options Medical for an undisclosed amount.

As part of deal, Lewisville, Texas-based Orthofix said that all employees of Options Medical were transitioned with the buy, which became effective February 1.

“Options Medical started in North Central Florida as a small team of hard working individuals who wanted to provide the best in medical device solutions to physicians. Today I am proud to say we have grown into a team of 40 plus who cover the states of Florida and Connecticut. We are excited to become a part of Orthofix and look forward to continuing our record of success for many years to come,” Options Medical founder Beth Stevenson said in a prepared statement.

“Options Medical has been a successful distributor for our bone growth therapies devices for many years. We are pleased to have this established and proven partner join the Orthofix team as a part of our direct sales force,” Orthofix spine global prez Brad Niemann said in a press release..

Last month, Orthofix saw shares rise slightly after it posted preliminary fourth quarter and full fiscal year 2018 earnings in line with Wall Street consensus.

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CHF Solutions inks Indian Aquadex FlexFlow distro deal

CHF Solutions

CHF Solutions (NSDQ:CHFS) said yesterday that it inked an agreement with Wayinia Lifesciences to distribute its Aquadex FlexFlow system in India.

The Eden Prairie, Minn.-based company said that the agreement will expand its sales outreach in Asia and open access to one of the larger population centers in the region.

“We continue to expand our presence worldwide and are pleased to extend the reach of our therapy with our Aquadex FlexFlow system into the Indian healthcare centers for patients who are chronically challenged by fluid overload when diuretics have failed. Heart failure is a global issue and there is a worldwide need to provide clinically proven tools to appropriately manage fluid overload.  We continue to grow our global presence and look forward to providing further updates as they become available,” chair & CEO John Erb said in a press release.

Last September, CHF Solutions said that it plans to expand into the post-cardiovascular surgery market, specifically with products for patients who need treatment for fluid overload and have failed diuretic therapy.

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InspireMD inks distro deal for CGuard in South Africa

InspireMD (NYSE:NSPR) said today that it inked a deal with Torque Medical to distribute its CGuard Embolic Prevention System in South Africa.

The Israel-based company reported that it will begin the commercial launch for CGuard in South Africa immediately.

“We are extremely pleased with the opportunity to offer CGuard EPS in the South African market. We were approached by some of our key customers in the Vascular Surgery, Interventional Neurology and Interventional Cardiology field who had learned about CGuard EPS through conferences and publications and wanted us to make it available in South Africa,” Craig Goodburn, managing member of Torque Medical, said in prepared remarks. “We see CGuard EPS as a key tool for fighting stroke caused by carotid artery disease in our country.”

“As awareness of CGuard among vascular surgeons, interventional neurologists, and cardiologists continues to grow through real-world experience, word-of-mouth, conference presentations, and publications, we are seeing more and more ‘pull-through’ demand in which treating physicians initiate contact with local distributors to make CGuard available in their market, such as what occurred in South Africa,” InspireMD CEO James Barry said.

“In our view, this is a very significant validation of our technology and a clear reflection of CGuard’s clinical advantages relative to both conventional carotid stents and carotid endarterectomy,” Barry added.

Last year, InspireMD won regulatory approval for its CGuard system and MGuard Prime device in Ecuador.

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Generex Biotech inks $1m deal to acquire distributor Medisource Partners

Generex Biotechnology, MediSource Partners

Generex Biotechnology said yesterday that it inked a deal to acquire medical and surgical product distributor Medisource Partners in a deal worth approximately $1 million.

Miramar, Fla.-based Generex said that the deal includes all assets of Medisource including its business operations, accounts receivable, inventory, contracts and real estate for $1 million worth of Generex stock, as well as additional cash and stock considerations for achieving certain sales and profit milestones.

“The strategic acquisition of Medisource Partners provides Generex with a value-added service model that fits the corporate mission of NuGenerex Distribution Solutions, adding immediate revenues and profits, while providing significant upside as we integrate the medical and surgical supply business into our current and future MSO networks. The extensive lines of surgical and biological products offered in the Medisource catalogue will enable us to expand our offerings to now include hospital systems, as well as our MSO partners. Our management services will not only integrate purchasing and billing, but will provide better pricing and access to new products, especially biologics, including platelet rich plasma, bone marrow aspirate, cord blood, and bone implants. We are excited that the acquisition of Medisource will provide access to a whole new line of products that not only enhances our current MSO network in the five states, but will eventually support the expansion of our MSO network into 27 states. We are in the process of completing the due diligence on this acquisition, with plans to close the transaction in the coming weeks,” Generex CEO Joe Moscato said in a press release.

Medisource Partners is currently contracted with more than 25 vendors to distribute implants and devices for spinal, hip, knee, foot, ankle, hand and wrist surgeries. The company distributes devices including biologics, durable medical equipment and soft goods, Generex said.

“MediSource Partners was founded in 2009 and designed to be unique amongst its competitors by operating as a service-focused, ‘one stop shop’ for the healthcare professionals it serves. With over 25,000 products in its catalogue, including thirteen lines dedicated to spine, Medisource prides itself on its ability to service everything from small private practices across several disciplines, to entire hospital systems. The large and broad-based inventory allows our client physicians to ‘customize’ their operating environment by selecting and implementing the hardware, biologics, soft goods and ancillary tools they feel most confident in and comfortable with. In addition, the ‘one stop shop’ model reduces the burden placed on support staff tasked with managing multiple reps from multiple vendors and shortens the distribution chain to reduce costs and potential redundancies. The success of this model is demonstrated in Medisource’s ability to offer this client-focused, low-impact service at a pricing matrix often below even standard GPO pricing, thus increasing client profitability and productivity,” Medisource CEO Travis Bird said in a prepared statement.

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Owens & Minor inks distribution deal with Scripps Health

Owens-MinorOwens & Minor (Mechanicsville, Va.) has signed a five-year medical and surgical supply distribution agreement with Scripps Health. The financial details of the deal were not disclosed.

Scripps Health is a California-based healthcare system that treats more than 750,000 patients annually. Under the agreement, Owens & Minor will serve Scripps Health’s five acute-care hospital campuses and the non-acute care, outpatient centers and clinics in Southern California.

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

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Reva brings bioresorbable scaffolds to new markets

Reva MedicalReva Medical (ASX:RVA) said this week that it inked four new distribution agreements, bringing its commercial operations to seven European countries.

The San Diego, Calif.-based company said the deals serve to expand the reach of its drug-eluting bioresorbable scaffold, Fantom Encore.

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

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Ascensia inks CGM distro, development deal with Poctech

Ascensia DiabetesAscensia Diabetes Care said this week that inked a deal to co-develop and distribute continuous glucose monitoring systems with device developer Poctech.

According to the terms of the deal, Ascensia will become the exclusive distributor for Poctech’s existing CGM product in 13 selected markets. Ascensia said it plans to start distributing the device in the second half of the year.

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

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DarioHealth inks U.S. distro deal for digital glucose meter

DarioHealth updated logoDarioHealth (NSDQ:DRIO) said today that it inked a deal with healthcare products provider Better Living Now for the distribution of its blood glucose monitoring system and the DarioEngage digital health program.

According to the terms of the deal, BLN plans to buy DarioHealth’s smart glucose meter and test strips to distribute to its customers. The agreement also enables BLN to provide diabetes management coaching to its customers through the DarioEngage platform on a monthly subscription basis.

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

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