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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Acelity’s KCI launches Abthera NPWT system in Japan

Acelity's KCI

Acelity subsidiary KCI said today that it launched its Abthera open abdomen negative pressure therapy system in Japan.

The San Antonio-based company’s Abthera is a temporary abdominal closure system intended to allow surgeons to manage challenging abdominal wall openings where primary closure is not possible and to manage repeat abdominal entries.

KCI said that the system has be validated in clinical studies, showing increased patient survival, improved primary fascial closure rates, shorter intensive care unit stays and improved outcomes.

“When dealing with patients managed with damage control for severe abdominal hemorrhage, abdominal compartment syndrome or severe peritonitis, using Abthera Therapy has been shown to be associated with proven patient outcomes. With the introduction of Abthera Therapy in Japan, clinicians now have a clinically demonstrated solution for a previously unmet, significant need, that manages the open abdomen at critical times, helping to achieve primary fascial closure more quickly,” Dr. Demetrios Demetriades of the Keck USC School of Medicine said in a press release.

“Japan is one of the largest healthcare markets in the world, and this launch fills a significant unmet need, allowing us to better support clinicians and their patients in the operating room. We are able to deliver leading-edge technologies like Abthera Therapy by expanding upon our unparalleled expertise in wound care to innovate new solutions for our customers,” prez & CEO R. Andrew Eckert said in a prepared statement.

Acelity’s KCI said last December that it inked a negative pressure wound therapy remote monitoring deal, using its iOn Progress remote therapy monitoring program, with health insurer Highmark, touting it as the first such agreement of its kind.

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Applied Tissue Technologies’ negative-pressure dressing gets FDA nod

Wound-care company Applied Tissue Technologies said it has won FDA clearance of its negative-pressure wound therapy product, the Platform Wound Dressing (PWD). The class II device represents the first-of-its-kind embossed negative pressure wound therapy device to be used without foam or gauze, according to the Hingham, Mass. company.

The PWD is a transparent dressing with an integral adhesive base and a permanently embossed, impermeable membrane that combines the traditional functions of the negative-pressure wound therapy membrane and foam/gauze in currently marketed negative-pressure devices. When the negative-pressure pump is switched on, the embossed membrane is pulled into direct contact with all geometries of the wound, eliminating the need for foam or gauze. The space created between the embossments provides primary channels for air and fluid, while folds in the membrane create secondary channels that provide an even distribution of negative pressure across the wound.

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

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European scientists develop absorbable bandages

Study co-author Elizaveta Permyakova of Russia’s National University of Science and Technology worked on developing the absorbable bandage.

An international research group has developed a biocompatible bandage material that has antibacterial properties and will not require changing, a potential boon for burn patients.

The material is self-absorbable, and a new bandage can be put directly on top of the old one, alleviating the need for the frequent and often-painful changing of a burn patient’s bandages. The bandages could also help patients with other wounds in which the healing skin is damaged by the changing of dressings.

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

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PolarityTE registers bone repair product with FDA

PolarityTE updated logoPolarityTE (NSDQ:PTE) said last week that it registered its bone repair product, OsteoTE, with the FDA.

The Utah-based company’s technology is an autologous, homologous product designed to repair, reconstruct and replace bone using a patient’s own cells.

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

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Acelity’s KCI inks NPWT remote monitoring deal with insurer Highmark

Acelity's KCI

Acelity subsidiary KCI said this week that it inked a negative pressure wound therapy remote monitoring deal, using its iOn Progress remote therapy monitoring program, with health insurer Highmark, touting it as the first such agreement of its kind.

The San Antonio-based company’s KCI iOn monitoring program is intended for use with the ACTIV.A.C therapy system, and includes monitoring, engagement and adherence components. KCI said that a remote monitoring device attached to the ACTIV.A.C system allows it to transmit data to KCI, where a team of virtual therapy specialists analyze data and use it to support healthcare professionals to improve adherence.

“The collaboration and agreement with KCI is just the latest example of Highmark’s commitment to working with providers in the health care industry to make sure our members receive high-quality care at an affordable price,” Highmark ancillary provider strategy & management VP Robert Wanovich said in a press release.

KCI touted that 73% of patients showed an increase in NPWT hours of use per day following adherence calls through the system, lowering the average 90-day wound-related costs. The company added that the program will create a “performance-based payment structure for reducing total wound care costs.”

“Since introducing the iOn Progress remote therapy monitoring system two years ago, we have learned a great deal about our NPWT patients through their engagements with our Virtual Therapy Specialist team – all of which have helped us develop and improve an impactful solution. Our aim is to create value across the continuum of wound care and iOn Progress remote therapy monitoring allows us to pursue that by better understanding each patient’s wound care journey. This unique insight allows us to engage patients and their caregivers like no other and better assist them through the healing process, which leads to better therapy adherence and ultimately, better outcomes and reduced costs,” KCI prez & CEO R. Andrew Eckert said in a press release.

Earlier this month, reports emerged suggesting that the privately held company may be considering taking the company public with an initial public offering.

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Will Acelity go public again?

Privately held Acelity may go public again, according to news reports this week.

London-based Apax Partners and a pair of Canadian pension funds acquired wound-care company Kinetic Concepts Inc. (now Acelity) for $6.1 billion in a leveraged buyout in 2011.  Apax is now mulling an initial public offering for Acelity by mid-2019, Bloomberg and the San Antonio Express-news reported. Bloomberg cited unnamed sources with knowledge of the possible IPO, the Express-News report said.

Apax has begun discussing a potential listing with advisers, the news outlets said. Sources told Bloomberg that an IPO could value Acelity at $5 billion.

“While we are always reviewing the strategic options available to our company, our policy is not to comment on market speculation and rumors,” Acelity spokesman Maggie Fairchild told MassDevice in an email.

In 2016, Acelity called off an initial public offering that could have fetched as much as $1 billion, citing market conditions.

Earlier this year, Acelity agreed to sell its Systagenix facility in Gargrave, England, to Scapa Healthcare and inked a deal to buy Crawford Healthcare. Then-KCI had acquired Systagenix for $485 million in 2013. The company united Systagenix, LifeCell and KCI under the Acelity brand in 2014 and sold LifeCell to Allergan for $2.9 billion in 2016.

Jim Leininger, M.D., an accident and emergency physician, founded KCI in 1976 to manufacture a critical care bed. KCI raised $50 million in its first IPO in 1988 and took itself private again in 1997, according to the Express-News. The company went public again in 2004, landing a listing on the New York Stock Exchange.

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Skin closure tech dev KitoTech Medical raises $2m

KitoTech Medical

Skin closure device maker KitoTech Medical has raised approximately $1.9 million in a new round of debt and options financing, according to a recently posted SEC filing.

The Seattle-based company has developed the MicroMend skin closure device, designed as an alternative to sutures, surgical glue and adhesives trips, according to the company’s website.

The MicroMend strips feature 1 mm micro staples embedded in an adhesive strip to anchor to the skin and close a variety of incisions and lacerations. The system comes in either a butterfly bandage or straight edge bandage, according to the site.

A total of 69 anonymous investors took part in the round, with the first sale dated on December 15, 2017.

The company is looking to raise an additional $1.1 million before it closes the offering, which would bring the total raised up to $3 million, according to the filing.

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Smith & Nephew up on Q3 sales gain

Smith & NephewInvestors pushed share prices for Smith & Nephew (NYSE:SNN) up in London and New York today after the medical device giant posted a third-quarter revenue gain and confirmed its outlook for the rest of the year.

The British orthopedics and wound care firm reported that sales grew 1.5% to $1.15 billion during the three months ended Sept. 29, powered by a 4.4% gain to $569 million for its U.S. business.

Sales in established markets outside the U.S. were off -3.4% to $393 million; emerging-market sales were $207 million, up 3.5%.

“Improved underlying revenue growth in the third quarter was led by growth in the U.S. and emerging markets. We are on-track to deliver our full year guidance,” CEO Namal Nawana said in prepared remarks. “These results were achieved whilst successfully redesigning how we will run the company. There is still more to do, and I am pleased with the pace of progress and engagement across the organization.”

Although it affirmed its forecast for underlying revenue growth of 2% to 3% this year, Smith & Nephew said it expects sales to come in at the lower half of the range.

The company also unveiled a new structural model involving its three main segments: orthopedics, sports medicine/ENT, and wound, each led by a president. Smith & Nephew downplayed the impact of the U.K.’s exit from the European Union, saying Brexit won’t have “a significant impact on our long-term ability to conduct business into and out of the EU or UK.”

“We are making good progress with our preparations for the various scenarios,” the company said.

The news sent SNN shares up 7.7% to $35.40 apiece today in pre-market trading in New York. In London, SN shares were up 6.3% to £13.54 each as of about 1 pm local time.

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Wound tech dev Clozex Medical raises $4m

Clozex Medical

Wound closure tech developer Clozex Medical raised approximately $3.8 million in a new round of equity financing, according to a recently posted SEC filing.

Funds in the round came from 39 unnamed sources, with the first sale dated on October 16, according to the filing.

Wellesley, Mass.-based Clovex is developing wound closure products intended to address limitations of traditional suture and stapling techniques. It’s flagship technology is Clozex Closures, which are intended for multiple uses, including plastic surgery, orthopedics, dermatology, cardiothoracic surgery, emergency medicine and urgent care, according to the company’s website.

The company is looking to raise an additional approximate $490,000 in the round, which would bring the total raised up to approximately $4.3 million, according to the SEC filing.

Clozex has not yet officially stated how it plans to spend funds raised in the round.

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