FDA approves Intact Vascular’s Tack dissection repair device

Intact VascularThe FDA last week granted pre-market approval to the Tack endovascular repair device developed by Intact Vascular.

The Wayne, Pa.-based company’s Tack system is designed to repair dissection complications during balloon angioplasty for peripheral artery disease. Intact said the federal safety watchdog based the April 11 PMA decision on the results of a pivotal, 213-patient single-arm trial that met both its safety and efficacy endpoints. The Tack device won CE Mark approval in the European Union in January 2017.

The Toba II study‘s rate of freedom from clinically-driven target lesion revascularization, amputation or all-cause death, its primary safety endpoint, was 86.5%. The trial met its efficacy endpoint with a 79.3% primary patency rate at 12 months. And 92.1% of all dissections were completely resolved, according to results presented at last year’s Vascular InterVentional Advances conference in Las Vegas by principal investigator Dr. William Gray.

Intact Vascular said the trial, which it touted as the first to enroll PAD patients with 100% dissected vessels, also showed 0.5% bailout stent rate and zero implant fractures.

“FDA approval of the Tack endovascular system comes at a dynamic time in the PAD market place. The Tack system’s unique combination of minimal metal and highly targeted dissection repair is an ideal fit with today’s focus on minimizing inflammation and improving long term outcomes,” president & CEO Bruce Shook said in prepared remarks. “Now with the Tack endovascular system available in both Europe and the United States, we look forward to expanding our commercialization efforts and continuing to improve the quality of life for PAD patients.”

“I look forward to having the Tack implant available for my patients,” added Gray, of Wynnewood, Pa.’s Lankenau Heart Institute. “Post-angioplasty dissections can significantly impact patient outcomes. Having a minimal metal solution that specifically addresses dissections and improves angioplasty results while preserving future treatment options is extremely exciting.”

Intact said it’s planning a limited U.S. release “that will progress toward broader market commercialization.” The company raised a $20 million Series C round in April 2018.

TissueTech raises $55m

TissueTech

TissueTech has raised approximately $55.3 million in a new round of equity financing, according to a recently posed SEC filing.

The Doral, Fla.-based company makes amniotic membrane- and umbilical cord-based products designed to treat ocular surface diseases (its Bio-Tissue subsidiary) and musculoskeletal conditions and wound care (its Amniox Medical business).

Money in the round came from three unnamed investors, with the first sale dated as having occurred on April 9, according to the filing.

The company is looking to raise an additional $27 million, which would bring the total raised up to approximately $82.3 million, according to the SEC filing.

TissueTech said that it plans to use a $10 million of the proceeds to repurchase from common stockholders on a pro rata basis, according to the SEC filing.

The company has not yet announced any other plans for the funds.

Ajax Health raises $85m for medtech investment

Ajax Health

Ajax Health, the company formed in 2017 by a pair of private equity giants to manage their medical device investments, said today that it has raised more than $85 million to help fund operations and expansions of select medical device companies.

The round was led by HealthQuest Capital and joined by Aisling Capital and Polaris Partners, the Menlo Park, Calif.-based company said.

“Ajax Health approaches medical device innovation in a novel way, applying best-in-class strategies to pinpoint technologies with the greatest opportunity to take off, then rapidly developing them into a fully integrated business. Ajax Health’s proven executive team, led by Duke Rohlen, Doug Koo and Aftab Kherani, has shown an exceptional ability to develop medical technologies successfully and cost efficiently,” HealthQuest founder & managing partner Dr. Garheng Kong said in a prepared statement.

Ajax Health said that it will seek to invest in companies with disruptive medtech devices with its newly raised funds, focusing on businesses with a potential for high-exit demand where returns could be realized within 48 months.

“I am extremely grateful to our partners HealthQuest, Aisling and Polaris for backing Ajax II. These firms have been exceptional partners for a long time and I look forward to working with them again,” Ajax Health chair & CEO Duke Rohlen said in a press release.

In May 2017 KKR and Aisling Capital joined to launch Ajax, tapping Spirox chairman & CEO Rohlen to lead it. Rohlen is the former president of FoxHollow Technologies and the founder & former chief executive of CV Ingenuity.

Last July, Ajax said that it raised a Series B round of $120 million.

Synaptive Medical raises $5m

Synaptive Medical

Synaptive Medical has raised approximately $5 million in a new round of debt and options financing, according to a recently posted SEC filing.

The Toronto-based company has not yet stated how it plans to spend funds raised in the round.

Synaptive Medical produces medical devices intended to facilitate surgical planning, navigation, robotic automation, digital microscopy and informatics through an interconnected platform, according to its website.

Money in the round came from a single unnamed investor, according to the filing, with the first date of sale noted as having occurred on March 26.

Last month, Synaptive Medical said that it named Sandra Clarke as its new finance chief.

Ex-MiMedx CEO Petit mounts proxy war

MiMedx

MiMedx (NSDQ:MDXG) is facing a proxy battle being led by former CEO Parker Petit, who was ousted last July “for cause”, according to a recently posted SEC filing.

The ex chief-exec nominated himself alongside former Pulte Home Corp tax director David Furstenburger and George & Lorenson partner Shawn George as candidates for the company’s board of directors, set to be elected at an upcoming shareholder’s meeting.

Petit said that he believes that the current MiMedx board has “failed shareholders with disappointing performance, failure to ensure competent leadership and lack of engagement with MiMedx shareholders.” He added that he “felt compelled to launch a contest seeking changes on the board,” according to the filing.

“In my opinion, the current board has done a major disservice to MiMedx’s shareholders and there is no sign the board has the ability, judgment or commitment to return MiMedx to its former growth and profitability as a NASDAQ listed company. Shareholders have been left in the dark while the company’s value has significantly dropped. I could no longer sit on the sidelines. Together with Shawn and David, we, if elected, will bring a wealth of experience working on and resolving expeditiously highly contentious and complicated matters. I believe that our slate of candidates will instill the much needed accountability and reason in the boardroom that MiMedx is now lacking, while supporting its valuable employees and expanding its best in class intellectual property patents,” Petit said, according to the SEC filing.

MiMedx faced a number of troubles last year, including the ouster of Petit and president & COO William Taylor amid a board-directed independent investigation that had already prompted the departure of CFO Michael Senken and treasurer John Cranston in June.

At the time, MiMedx said it would restate all of its earnings reports going back to 2012 and was cooperating with U.S. Securities & Exchange Commission and Justice Dept. investigations into the matter.

The company later said that all four executives’ departures were for cause, triggering the forfeit of all equity and incentive awards for the executives and Petit’s resignation from the board. Petit and Taylor denied the allegations in a statement from their lawyer.

In December, the accounting firm tapped to audit MiMedx’s books resigned in the wake of the financial issues the company faced.

Pennsylvania appeals court upholds $14m plaintiff win in Ethicon mesh case

J&J's EthiconA state appeals court in Pennsylvania yesterday upheld the plaintiff’s $13.7 million win in a product liability lawsuit brought over one of Johnson & Johnson (NYSE:JNJ) subsidiary Ethicon‘s pelvic mesh products.

Plaintiff Sharon Carlino was awarded $13.5 million in damages in February 2016, after a Keystone State jury found that the Ethicon transvaginal polypropylene tape implanted during a 2005 hysterectomy was defective and that the company failed to adequately warn of its risks; Carlino needed three revision surgeries to remove the eroded mesh. That decision was upheld early the following year, with the court adding some $238,000 in delay damages.

Ethicon and Carlino cross-appealed, with the company pressing seven arguments seeking to overturn the decision and Carlino arguing that the delay damage award should have been calculated on both compensatory and punitive damages, not just the compensatory award.

Yesterday the Pennsylvania Superior Court ruled on the cross-appeals, backing the lower court’s decision on all fronts, including Ethicon’s challenge to the punitive damages award and the delay damages ruling.

“Taken as a whole, and viewed in the light most favorable to the verdict winner, this evidence permitted the jury to find Ethicon acted with wanton and willful disregard of Ms. Carlino’s rights and that this conduct caused her injuries. The evidence showed that Ethicon knew that the TVT could cause permanent vaginal and muscular pain and sexual dysfunction, because of its mesh weight, pore size, pore collapse, and particle loss. Despite this knowledge, Ethicon promoted the TVT for patients who sought to fix SUI, knowingly understated the risks of the TVT in its IFU, and consistently misled physicians that the TVT produced few adverse results,” the Superior Court found.

“The evidence demonstrates that Ethicon knowingly understated the risks of the TVT in all six versions of the [instructions for use] published between 2000 and 2015. The IFU’s adverse reactions section did not change during that time, and it failed to acknowledge new information Ethicon was obtaining from treaters and its own researchers on adverse effects associated with the TVT. In addition, Ethicon consistently and misleadingly informed physicians that the TVT produced few adverse results and was intentionally evasive about common complications,” according to the ruling.

In January a Philadelphia jury hit Ethicon with a $41 million decision in another pelvic mesh suit brought over its Gynemesh, Prolift and TVT-O meshes. That verdict includes $25 million in punitive damages, $15 million in compensatory damages and $1 million for loss of consortium.

Ethicon has said it intends to appeal the decision and that it stands by its pelvic mesh products.

Align Technology puts $31m price tag on forced retail store closures

Align Technology

Align Technology (NSDQ:ALGN) yesterday put a price tag of as much as $31 million on the forced closure of its Invisalign retail outlets after losing arbitration with SmileDirectClub last month.

The March 4 decision required San Jose, Calif.-based Align Technology to close the stores by April 3 and enjoined it from opening new Invisalign stores or providing clear aligner devices in brick-and-mortar stores.

First piloted in 2017, the number of Invisalign stores had risen to 12 by last year. Yesterday the company said it expects the closures to result in first-quarter charges of between $26 million and $31 million, including cash payments of $12 million to $17 million this year.

The charges involve $11 million to $16 million in right-of-use lease assets, $14 million in leasehold improvements and other fixed assets and severance expenses of $1 million, Align said in a regulatory filing.

Obalon taps Cowen to explore ‘strategic alternatives’

Obalon TherapeuticsObalon Therapeutics (NSDQ:OBLN) today tapped an advisory firm to explore “strategic alternatives,” a week after revealing plans to cut its workforce in half.

The Carlsbad, Calif.-based company, which makes a gas-filled balloon designed to treat obesity, said April 3 that it would lay off 49 of its 100 employees, including all of its direct sales force, in a pivot toward retail.

Today the company said it hired investment bank Cowen “as an independent financial advisor to assist in exploring financial and strategic alternatives” to explore “a wide range of financial and strategic alternatives.”

“Obalon will proceed in an orderly manner to identify and evaluate possible financial and strategic alternatives for the company and their implications,” Obalon said “No assurance can be given as to whether any particular financial or strategic alternative will be recommended or undertaken, and if so, upon what terms and conditions.”

The company said it plans to stay mum until its board approves a transaction or until a statement is required by law.

OBLN shares, which plunged -21% last week after the restructuring news broke, were off by as much as -11.6% today before rallying to 58¢ apiece today in late-morning activity, down -1.0%.

Intrinsic Therapeutics raises $52m for Barricaid annulus seal

Intrinsic Therapeutics

Intrinsic Therapeutics said today that it raised $52 million in a new round of equity financing to support the U.S. commercialization of its Barricaid annulus seal.

The Boston-based company’s Barricaid implant is a polymeric mesh that is designed to sit at the posterior intervertebral disc space and is connected to a metal anchor that is attached to the vertebral body. The device is intended as an adjunct for lumbar limited discectomy to replace missing or damaged parts of the annulus to prevent re-herniation, disc collapse, the return of sciatica and potentially to help stave off low back pain.

Intrinsic Therapeutics won FDA approval for the Barricaid in February despite the fact that the prosthesis received a 5-8 advisory panel against recommending approval in December 2017.

“Recurrent lumbar disc herniations have been shown to cause significant disability for patients and expense for our healthcare systems. The Barricaid clinical trial highlights a technology that can reduce the burden from this spinal condition which deserves close evaluation from all who manage this complication,” Dr. Wellington Hsu of Northwestern University said in prepared remarks.

The Series Growth equity round was led by Questa Capital and joined by existing investors New Enterprise Associates, Greenspring Associates, Quadrille and Delos Capital.

“Questa invests in healthcare innovations that deliver value by providing improved clinical outcomes at an acceptable cost.  By cutting reoperation rates in half, Barricaid can help prevent chronic disability, improve quality of life, and prevent a degenerative spiral. The odds of a patient not returning to work are nearly three times higher after a revision surgery, therefore preventing reherniation is critical,” Questa Capital founder & managing director Ryan Drant, who will join the company’s board of directors in connection with the financing, said in a prepared statement.

“We are extremely pleased that Questa led this financing to support our U.S. commercialization efforts for the Barricaid device. Meaningful clinical data demonstrate that treatment with Barricaid can reduce reherniations and repeat surgeries for patients, and we’re excited to welcome Questa to our fantastic group of investors as we execute a strategic market release in the United States,” Intrinsic Therapeutics CEO Cary Hagan said in a press release.

BioCardia registers for $18m offering

BioCardia

BioCardia (NSDQ:BCDA) has registered for an upcoming offering of its common stock, looking to raise approximately $18 millions according to an SEC filing.

The company has not yet set a price range for the offering, nor has it stated how many shares it is looking to float.

San Carlos, Calif.-based BioCardia did note the closing price of its stock on April 8 as being $1.33 per share.

The offering will include warrants to purchase additional common stock, according to the filing.

Last December, BioCardia said that it submitted an application for FDA 510(k) clearance for its Avance steerable introducer intended for introducing cardiovascular catheters into the heart, including the left side of the heart through the interatrial septum.