MiMedx top brass resign amid internal accounting investigation

MiMedx CEO Parker H. “Pete” Petit and COO and President William C. “Bill” Taylor have resigned as a board-directed independent investigation continues into accounting practices, Marietta, Ga.–based MiMedx (Nasdaq: MDXG) announced today.

Petit and Taylor’s exit comes after recent departures of MiMedx’s CFO and corporate controller and treasurer. In addition to the resignations of top brass, the regenerative and therapeutic biologics company now plans to restate all of its earnings reports going back to 2012. The company says it is cooperating with U.S. Securities and Exchange Comission and Department of Justice investigations.

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

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Feds indict 9 in $950m Operation “Spinal Cap” fraud case

US federal prosecutors with the Department of Justice this week unsealed charges against nine new defendants they claim are part of a long-running healthcare fraud case responsible for more than $950 million in fraudulent claims.

The fraud scheme was reportedly run by former Long Beach, Calif.-based Pacific Hospital owner Michael Drobot, who was involved in more than $40 million in illegal kickbacks paid to medical professionals in exchange for referrals for patients who received treatment at the hospital, according to a DoJ release.

Included in the charges are Pacific Hospital orthopedic surgeons Daniel Capen, Timothy Hunt and Tiffany Rogers, former Pacific Hospital physician management CFO George Hammer, chiropractors Lauren Papa and Brian Carrico, and Willian Parker.

Capen, Hunt, Hammer and Papa have agreed to plead guilty for their parts in the scheme, according to the DoJ release.

The Department of Justice said that fraudulent claims related to the scheme span a 15-year period and cumulatively total more than $950 million.

The investigation is being conducted by the FBI, IRS Criminal Investigations, the California Department of Insurance and the US Postal Service’s Office of Inspector General.

“Public health insurance programs – whether a workers’ compensation program or Medicare – are not a personal pocketbook for criminals seeking to exploit government programs designed to help those who need these plans the most. Taxpayers rightly expect individuals working in the healthcare industry that receive payments from taxpayer-funded programs to scrupulously follow the rules. IRS Criminal Investigation will continue to protect the integrity of public health insurance programs and ensure that doctors, pharmacists and medical service providers who profit from these illicit schemes are held accountable,” IRS Criminal Investigation special agent in charge of the Los Angeles Field Office R. Rowe said in a prepared statement.

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Insulet assumes direct commercial operations in Europe

Insulet (NSDQ:PODD) said today that it has assumed direct commercial operations in Europe for its Omnipod tubeless insulin pump.

The Billerica, Mass.-based company first announced it would part ways with its former European distributor, Ypsomed, in July last year. Insulet has since established a team of more than 100 employees to take care of distributing and selling its Omnipod system in Europe, the company reported.

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

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Paulsen takes another run at repealing the medical device tax

Rep. Erik Paulsen (R-Minn.), facing a tough re-election campaign, is taking yet another run at repealing the medical device tax.

Althought the 2.3% levy on prescribed medical devices was enacted as part of the Affordable Care Act in 2010, it didn’t go into effect until 2012 and was mothballed two years later; that moratorium, extended earlier this year, is slated to end in 2020.

Paulsen, who filed his first bill to repeal the tax back in 2010, introduced his latest repeal bid in January 2017. The bill, H.R. 184, or the “Protect Medical Innovation Act of 2017,” aims to “amend the Internal Revenue Code of 1986 to repeal the excise tax on medical devices.” The bill has 269 co-sponsors, including 43 Democrats.

Citing “sources familiar with the plan,” The Hill reported yesterday that the U.S. House of Representatives could vote on the Paulsen bill as early as this month. That could help Paulsen’s campaign against Democratic businessman Dean Phillips in a district that Hillary Clinton won by a 10% margin in 2016 that’s also a hotbed for the medtech industry. That race is a “toss-up” according to the Cook Political Report, which gave Phillips a +1 chance of winning the contest as of June 20.

“We’ve got a lot of little companies that want to become the next Medtronic or Boston Scientific, so, yeah, I’m sure it’s something we’ll be talking about in terms of getting something done in an atmosphere where it’s tougher to get stuff done,” Paulsen told The Hill. “We’re kind of thinking if we get a big vote like that it will actually show the Senate we want to get this done.”

Phillips is also on record as opposing the medical device tax, the website reported.

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Novartis steps in to compete with Mylan’s Epipen

Adamis Pharmaceuticals (NSDQ:ADMP) said this week that it inked an exclusive deal with Novartis‘ (NYSE:NVS) Sandoz unit to distribute and commercialize its Symjepi emergency allergy treatment.

The agreement puts Novartis in the position to compete directly with Mylan‘s (NSDQ:MYL) EpiPen auto-injector. The pharma giant has been under pressure in recent months thanks to manufacturing delays that have caused an Epipen shortage in the U.S.

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

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TransEnterix jumps on Q2 prelims

TransEnterix (NYSE:TRXC) shares got a jump today when the robot-assisted surgery company released preliminary revenue numbers for the second quarter that outstripped the consensus on Wall Street.

Research Triangle Park, N.C.-based TransEnterix said it expects to post sales of $6.0 million to $6.3 million for the three months ended ended June 30, 2018, up 300% to 320% compared with Q2 2017. Analysts on The Street were looking for sales of $5.4 million.

TransEnterix also revealed another sale of its Senhance device via distributor for Europe, Middle East, & Africa last month, taking the June sales tally to four systems.

“We had a strong second quarter as we continued to drive sales of Senhance globally while at the same time making significant progress towards our 2018 goals, including the expansion of Senhance’s indications for use and portfolio of instruments,” said Todd M. Pope, President and CEO at TransEnterix. “We look forward to continuing to build upon the momentum we developed during the first half of the year to drive the widespread adoption of Senhance.”

TransEnterix said it had about $98 million in cash & equivalents as of June 30.

TRXC shares were up 8.7% to $4.74 apiece today in pre-market trading.

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Ocugen launches Ph3 trial for eye disease nanoemulsion

Ocugen said today that it launched the first of two pivotal Phase III trials for its OCU300 nanoemulsion designed to treat the symptoms of ocular graft versus host disease.

The Malvern, Penn.-based company’s drug is a nanoemulsion formulation of brimonidine tartrate made using Ocugen’s OcuNanoE technology.

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

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