Unilife jumps on $15m Amgen injector deal

Unilife (NSDQ:UNIS) saw shares jump over 50% after signing a $15m deal with Amgen (NSDQ:AMGN) that positions the company to offer Amgen its wearable injector devices.

The  strategic partnership included a non-refundable $15 million deposit from Amgen, who will use Unilife’s wearable injector devices along with “certain large volume drug products”.

The deal also included a perpetual exclusive license for Unilife’s 1mL wearable injector for use with Amgen’s small volume drug products, according to the SEC filing.

Unilife will still develop most of the injectors, with Amgen footing the bill for each device manufactured for its use, according to the filing. If Unilife can’t keep up production, Amgen will be able to source the manufacturing elsewhere with a 10% royalty going to Unilife.

The deal included a caveat which will allow Amgen to source 20% of their annual volume elsewhere, with Unilife receiving the difference per unit between their price and the manufacturing and procurement cost.

Shares in York, Penn.-based Unilife surged today, rising 53.5% to 76¢ as of 12:26 p.m. EST.

The deal is good news for the company, who last October said it tapped chairman & CEO Alan Shortall for a loan so it could avoid defaulting on its $60 million debt with OrbiMed.

Unilife said it borrowed $600,000 from Shortall so it could maintain the $5 million cash balance required by the OrbiMed loan and still make a payment on the loan.

The investment fund also agreed to put up another $10 million in debt funding for Unilife, the company said.

Unilife, which slashed 17% from its workforce in September, said earlier that month that it’s exploring the proverbial “strategic alternatives.” In October, the company said it’s “received interest” from several parties.

The post Unilife jumps on $15m Amgen injector deal appeared first on MassDevice.

from MassDevice http://ift.tt/1mvwqCr

Endotronix pulls in $3.5m for wireless heart monitor

Endotronix raised $3 million and is looking to bring in another $540,000 in a new round of debt financing, according to an SEC filing posted last week.

Woodridge, Ill.-based Endotronix develops wireless cardiac monitors, including a ‘tiny pressure sensor’ designed to be implanted in a patient’s pulmonary artery during a catheterization procedure, to wirelessly return PA pressure to portable reader device, according to the company’s website.

Data from the device can be transmitted to healthcare providers through a wireless link to Endotronix software, and is stored and analyzed by the company’s system.

The money from the round comes from 25 unnamed investors, and Endotronix has not yet said what it plans to do with the funds raised from the round, according to the SEC filing.

The post Endotronix pulls in $3.5m for wireless heart monitor appeared first on MassDevice.

from MassDevice http://ift.tt/1ZKuN1O

FDA slaps PMA requirement on pelvic mesh

The FDA, prompted by a significant increase in complaints about a type of surgical mesh used to treat pelvic organ prolapse in women, put the product under its most stringent level of review.

The federal safety watchdog said it re-classified the mesh from Class II to Class III and will require makers to go through its pre-market approval process for transvaginal POP procedures. The moves do not apply to mesh used in other indications, including stress urinary incontinence and abdominal POP repair, the FDA said.

“These stronger clinical requirements will help to address the significant risks associated with surgical mesh for repair of pelvic organ prolapse,” said Dr. William Maisel, deputy science director & chief scientist for the agency’s Center for Devices & Radiological Health, said in prepared remarks. “We intend to continue monitoring how women with this device are faring months and years after surgery through continued postmarket surveillance measures.”

An estimated 100,000 product liability lawsuits have been filed in state and federal courts across the country against pelvic mesh makers, including Johnson & Johnson (NYSE:JNJ) subsidiary Ethicon, Boston Scientific (NYSE:BSX) and C.R. Bard (NYSE:BCR).

Companies that make pelvic mesh for transvaginal POP procedures have 30 months to file PMA applications with the FDA for devices already on the market. The agency warned about the risks of pelvic mesh in 2008 and 2011, but in 2014 refused to ban U.S. sales of the implants, rejecting in large part a petition filed by consumer advocacy group Public Citizen.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

The post FDA slaps PMA requirement on pelvic mesh appeared first on MassDevice.

from MassDevice http://ift.tt/1O6mXIn

InVivo Therapeutics wins FDA approval for pivotal trial of spinal scaffold

InVivo Therapeutics (NSDQ:NVIV) said today that it won FDA approval to shift a pilot trial of its spinal scaffold to a pivotal probable benefit study.

Cambridge, Mass.-based InVivo said it expects the FDA to OK its Inspire study, designed to enroll 20 patients with spinal cord injuries, after it submits 6-month data during the 2nd quarter from 5 patients already enrolled in the pilot study.

InVivo’s neuro-spinal scaffold is a bioabsorbable device designed to treat acute spinal cord injuries. The company said it’s discussing the Inspire study’s objective performance criterion for probable benefit, using historical benchmarks, with the federal safety watchdog.

“Receiving full approval to convert our pilot study into a pivotal probable benefit study is a significant step forward for InVivo,” chairman & CEO Mark Perrin said in prepared remarks. “It is extraordinary to think that just over a year after enrolling the 1st patient in our study, we are now running a pivotal trial with planned international expansion and the intent to file an application for HDE approval in just 2 years.”

The post InVivo Therapeutics wins FDA approval for pivotal trial of spinal scaffold appeared first on MassDevice.

from MassDevice http://ift.tt/1OGw87R

Bosch gets in on $3m Series B for Emperra’s ‘smart’ diabetes system

Emperra said today that it closed a Series B round worth $3.1 million for its Esysta “smart” diabetes management system.

Potsdam, Germany-based Emperra said the VC arm of the Bosch Group, Robert Bosch Venture Capital, joined existing backers Peppermint VenturePartners and Investitionsbank des Landes Brandenburg. CEO Christian Krey and CTO Dr. Janko Schildt also got in on the round, Emperra said.

Esysta, which uses a Bluetooth-enable insulin pen and a wireless blood glucose meter to monitor diabetes patients, won CE Mark approval in the European Union and reimbursement coverage from German health insurers, Emperra said. Patients and healthcare providers can view data from the system via a web portal, smart TV and mobile device apps, the company said.

The Series B funding is earmarked for product development and sales growth in the U.S. and Europe, Emperra said.

“Involving high-quality investors such as Bosch demonstrates the potential in our unique approach to diabetes care,” Krey said in prepared remarks. “In particular, having Bosch as a strategic investor means we have access to its global expertise in software automation, connected communities, and sensor technologies.”

“As 1 of the lead investors of the Series A round, we continued to support Emperra by participating in the B round. We are pleased to add RBVC to our syndicate, and hope it will accelerate Emperra’s expansion into international markets,” added acting chairman Klaus Stoeckemann of Peppermint VenturePartner.

The post Bosch gets in on $3m Series B for Emperra’s ‘smart’ diabetes system appeared first on MassDevice.

from MassDevice http://ift.tt/1Z0Whho

Sectra buys Swedish imaging company RxEye

Sectra (OMX:SECTB) said it acquired RxEye AB and its cloud-based medical imaging platform for an undisclosed amount on Dec. 30, 2015.

The RxEye Cloud service is used to remotely view images by more than 2,000 users in European radiology, nuclear medicine and pathology departments and teleradiology services companies, Linköping, Sweden-based Sectra said. RxEye, which employs 6 workers, posted sales of about $833,000 last year (SEK 7 million), Sectra said.

“Providing services to the medical care sector via the Internet is a delivery model that we can see is increasing in importance and remote viewing of medical images is a growing area due to efficiency requirements and, in certain cases, staff shortages in the medical care sector,” says Torbjörn Kronander, President and CEO of Sectra. “RxEye is a small company with products that complement our offering of IT services, which can enhance the efficiency of communication and use of resources in medical care.”

“As a result of this transaction and the accompanying access to Sectra’s customer and sales network, the service can continue to be developed and contribute to simplifying the everyday work of radiologists and pathologists,” Lars Henriksson, investment manager at Industrifonden, 1 of RxEye’s former principal owners, said in prepared remarks.

Sectra said it will integrate RxEye into its imaging IT solutions business. The deal includes a cash payment and additional milestones, the company said.

The post Sectra buys Swedish imaging company RxEye appeared first on MassDevice.

from MassDevice http://ift.tt/1Rb1iF2

Helius draws down $5m, reups U.S. Army deal

Helius Medical Technologies (OTC:HSDT) said it drew down on the $5 million remaining in its credit facility from a Chinese investor and extended a research deal with the U.S. Army.

Newtown, Pa.-based Helius said that in return for the draw-down, it gave A&B Co. Ltd., its partner in a deal to develop and commercialize its Portable Neuromodulation Stimulator in Asia, nearly 5.6 million shares and a 3-year warrant for another 2.8 million shares at $1.35 apiece.

 

A&B appointed general manager Dr. Huaizheng Peng to the company’s board as part of the draw-down, Helius said.

The company said it also extended until Dec. 2017 a deal with the U.S. Army Medical Research & Material Command for a 120-patient, Phase III clinical trial of Helius’ portable neuromodulation stimulator for treating balance disorder in patients with mild to moderate traumatic brain injury.

“We are very pleased to be formally extending our partnership with the U.S. Army through 2017. Partnerships such as this are crucial to Helius’ development of the PoNS in both the clinical and commercial settings,” CEO Philippe Deschamps said in prepared remarks.

Helius said it also added Blane Walter, a partner at Talisman Capital, to its board.

Helius said it named board member Joyce LaViscount to be its new CFO/COO, replacing Amanda Tseng, who retired. CFO/COO Joyce LaViscount and director Yuri Danilov resigned from the board to make room for Peng and Walter, the company said.

“Helius wishes to express its thanks to Ms. LaViscount and Dr. Danilov for their invaluable contributions throughout their tenure as directors,” the company said.

The post Helius draws down $5m, reups U.S. Army deal appeared first on MassDevice.

from MassDevice http://ift.tt/22GGgBS