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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Acera Surgical raises $5m

Acera Surgical

Acera Surgical has raised $5.1 million in a new round of equity financing, according to a recently posted SEC filing.

The St. Louis-based company is developing an implantable nanomedical scaffold intended for medical applications including soft tissue repair, according to a St. Louis Business Journal report. Acera also produces a protective wound cover called Restrata.

Acera licensed the surgical mesh technology behind their products from the Washington University Office of Technology Management in 2012, according to the article.

A total of two anonymous investors have joined in the round, with the first sale dated on October 5, according to the SEC filing.

The company is looking to raise an additional $5 million in the round, bringing the total raised up to $10.1 million.

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

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Avita launches pediatric burn trial

Avita Medical

Avita Medical (ASX:AVH) said today that it launched a new trial of its Recell autologous cell harvesting device exploring its use treating pediatric patients.

The Recell autologous cell harvesting device is designed to use the patient’s own skin cells to treat a variety of skin issues, including burns, reconstructive and cosmetic procedures, the Valencia, Calif.-based company said.

In the newly launched trial, investigators will compare use of the Recell device to the standard of care for approximately 90 patients under 18 years of age. Patients in the trial will be randomized to be treated with either the Recell system and Biobrane dressing, the dressing alone or the standard of care, silver impregnated silicone lined dressing.

The trial’s primary endpoint will be days to re-epithelization of burn injuries, while secondary endpoints will include pain, patient satisfaction and scarring, according to a press release.

Last month, Avita Medical said that it won FDA premarket approval for its Recell autologous cell harvesting device, now cleared for use in treating severe thermal burns in patients 18 and older, and that it plans to launch the device in the fourth quarter.

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FDA deals warning letter to Ocular over eye sealant

Ocular Therapeutix - updated logoOcular Therapeutix (NSDQ:OCUL) said today that it received a warning letter from the FDA over its ReSure hydrogel ocular wound sealant.

The warning letter, dated Oct. 17, relates to Ocular’s compliance with data collection and reporting obligations in a post-approval device exposure registry study, according to the company. The registry study was a condition for approval of the premarket approval application for Ocular’s ReSure product.

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

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MolecuLight wins FDA de novo nod for handheld fluorescence wound imager

MolecuLight said yesterday it won FDA de novo clearance for its MolecuLight i:X designed to assess wound surface area and help visualize harmful bacteria within the wounds.

The device is designed to improve wound assessments, which are currently made without tools, the Toronto-based company said. The system uses fluorescence to help visualize potentially harmful bacteria which may other be missed.

The device won indications from the FDA as a handheld imaging tool that allows for the diagnosis and treatment of skin wounds at the point of care. The system also allows for the viewing and digital recording of wounds traditionally and through fluorescence emitted images of wounds exposed to an excitation light.

“The MolecuLight i:X platform is a significant advancement in the management of chronic wounds, that is already revolutionizing wound care practice in Canada and Europe. Thousands of patients to date have already experienced a change in their assessment and treatment by clinicians who feel empowered by the wound fluorescence images they are seeing. As reported in multi-centered published clinical studies, clinicians used the images to inform their wound management practices in real-time, in particular, for guided wound sampling, cleaning and debridement.  We’re very excited that US clinicians will soon have the same access to this device as their peers in Canada and Europe,” founder & chief scientific officer Dr. Ralph DaCosta said in a prepared statement.

“FDA marketing authorization of the MolecuLight i:X is a monumental milestone for the wound care industry. Thanks to continued clinical studies and 17 publications to date, the clinical evidence is rapidly accumulating that the MolecuLight i:X is a must‑have device in the hands of all wound care clinicians,” CEO Anil Amlani said in a press release.

Last December, Smith & Nephew (NYSE:SNN), which distributes for MolecuLight, said it launched the MolecuLight i:X handheld imaging device in Europe.

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Gel-E wins FDA OTC nod for gel-e Flex flowable hemostat

Early stage wound care company Gel-e said today it won FDA 510(k) clearance for its gel-e Flex as an over-the-counter flowable hemostat.

The College Park, Md.-based company said the clearance expands the labeling for the local management of lacerations and minor bleeding, and said the products were specifically designed to be usable by both trained professionals and patients.

“This clearance is the next step in expanding our OTC product line, and will be a key component of gel-e’s 21st Century First Aid Kit. We are continuing to develop a tool kit that will provide the best possible options for all manner of chronic and acute wounds. The versatility of these flowable and bandage formats represents an important progression towards our next-generation kit and eventually to products that can be used in surgery,” chief scientific officer Dr. Matthew Dowling said in a press release.

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Avita raises $12m for US debut of Recell device

Avita Medical (ASX:AVH) said yesterday that it raised $12.3 million to back the U.S. launch of its Recell wound treatment.

Melbourne- and Valencia, Calif.-based Avita said the A$16 million round, raised from a consortium of institutional and “sophisticated” investors led by Bell Potter, consists of two tranches: $9.8 million (A$12.8 million) that’s slated to close June 12, and a $2.5 million (A$3.3 million) tranche that must be approved at the company’s July shareholders meeting.

The A50¢-per-share price is a -3.8% discount to Avita’s June 1 closing price and a -6.3% discount to its 30-day volume-weighted average price, the company said.

Avita said it expects the FDA to complete a review of Recell’s pre-market approval bid during the third quarter, “followed by U.S. approval and market launch.”

“We appreciate the support of our shareholder group and the investors in this institutional placement as we proceed toward a transformative series of events for Avita, including the U.S. market launch of the Recell device,” CEO Dr. Michael Perry said in prepared remarks. “Proceeds from this placement will ensure that we are positioned to take full advantage of the expected upcoming PMA approval of the Recell device in the U.S., including establishment of our marketing and sales team, scale-up of manufacturing capabilities and expansion of research and development in areas such as pediatric burns, aesthetics and chronic wounds. The extensive series of clinical data presented at the recent ABA and ISPOR conferences strongly supports the value of Recell in the treatment of severe burns, and we have an exceptional commercial opportunity resulting from the unique combination of improved patient outcomes and substantial health economic benefits.”

“We are pleased to move toward the completion of this institutional placement to ensure that resources are in hand to strengthen our position and ensure that we are fully enabled to take advantage of opportunities facing us, including the upcoming U.S. launch of the Recell device,” added CFO Dale Sander. “We note that the issue price of this institutional placement is higher than that of our last financing round, and is within the range at which our shares have traded for the past 30 days.”

($1 = A$1.30310)

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Avita Medical touts pivotal trial of ReCell burn injury device

Avita Medical (ASX:AVH) said today that a pivotal trial of its ReCell autologous cell harvesting device met its co-primary endpoints.

The device, designed to help heal deep, full-thickness burns, demonstrated a statistically significant reduction in donor skin requirements compared to the standard of care and achieved comparable wound closure, Avita touted.

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

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