A BB&T Staff Report

MagForce Nanotechnologies (Berlin) reported last month that it has signed a standby equity distribution agreement (SEDA) with YA Global Master SPV, an investment fund managed by Yorkville Advisors.

MagForce now has the option over the next 36 months to avail itself of a binding commitment by YA Global to subscribe to and purchase multiple tranches of newly issued shares from the company's approved capital up to a total amount of €20 million ($26 million). MagForce says it will retain complete discretion over if and when it makes use of its rights over the life of the option.

The commitment provides MagForce with flexible access to additional equity capital of up to €20 million, thus ensuring that the company retains a sound basis of financial comfort as it enters the rapidly approaching commercialization phase and further expands its R&D pipeline.

Nanobiotix closes $11M 'C' round

Nanobiotix (Paris), a company developing therapeutic products for cancer using nanotechnologies, last month reported the closing of an $11 million Series C financing round.

Nanobiotix raised the money from a strong new and existing syndicate of investors. CIC Vizille Capital Innovation has led this new round with Masseran Gestion. Existing shareholders also participated in the round including, Matignon Technologies, OTC Asset Management, Cap Decisif Management, and Amorçage Rhône-Alpes.

The company's NanoXray therapeutic platform is designed to enable the precise destruction of cancer cells made possible by the controlled application of an outside-the-body energy source, in that case an X-ray. The nanoparticles that comprise the nanoXray platform allow for an extensive combination of therapeutic modalities and malignant pathologies. Nbtxr3, the first product to be developed from the nanoXray pipeline, also is the first-in-class product to be activated by radiotherapy.

Winner Medical closes $8.4M stock offering

Winner Medical Group (Shenzhen, China), a manufacturer of medical dressings and disposables, reported in May that it has closed its offering of 1.38 million shares of common stock.

Winner Medical received about $8 million in net proceeds from the offering, which it intends to use to expand the production capacity of its PurCotton product line and for general corporate and working capital purposes.

Roth Capital Partners acted as the sole book-running manager for the public offering, and Maxim Group acted as co-manager.

UK issues alert for metal-on-metal hip devices

The UK's Medicines and Healthcare products Regulatory Agency (MHRA) issued a medical device alert in late April requesting that UK orthopedic surgeons further investigate the cause of pain in patients with painful metal-on-metal hip arthroplasties and resurfacings.

In the April 22 alert, the MHRA said it received reports about revisions of these implants involving soft tissue reactions, which may be associated with unexplained hip pain.

The alert is not a recall affecting all UK patients with a metal resurfacing arthroplasty, the group noted.

The MHRA asked that orthopedic departments and surgeons, hospital medical directors and others perform annual follow-ups in asymptomatic patients for five years and more frequent follow-ups in symptomatic patients.

In some patients, blood metal-ion measurements and cross-sectional imaging should be performed, the UK health officials noted.

The British Orthopaedic Association (BOA; London) and the British Hip Society (BHS; London) have issued a five-page document to help orthopedic surgeons interpret the alert.

The joint BOA and BHS document provides details on blood collection techniques and lists seven laboratories that can analyze blood, synovial fluid and urine samples for trace elements.

No agencies outside the UK, including FDA, have issued any similar alerts.

PerkinElmer launches prenatal IVD assay

At the 10th International Congress on Preimplantation Genetic Diagnosis in Montpellier, France, PerkinElmer (Waltham, Massachusetts) reported the introduction of its new prenatal BACs-on-Beads (BoBs) in vitro diagnostic (IVD) assay for rapid prenatal testing of multiple genetic diseases, for use in the European Union.

The Prenatal BoBs assay is the first IVD product from the BACs-on-Beads multiplexed bead-based technology product family. The assay is a solution for IVD use in cytogenetics laboratories for analysis of chromosomes linked to major genetic diseases affecting newborns and their families. Prenatal BoBs can test for multiple chromosomal abnormalities simultaneously from minute amounts of DNA sample, with results obtained in less than 24 hours, according to the company. Additionally, clinicians can analyze more than 40 samples at once for high throughput diagnostic capability, PerkinElmer noted.

The prenatal BoBs assay is a CE-marked molecular karotyping technology that enables targeted detection of DNA gains and losses in carefully chosen, prenatally relevant genomic regions. The assay detects aneuploidies of chromosomes 13, 18, 21, X and Y, as well as DNA copy number changes in 9 microdeletion syndrome regions. By concentrating on regions linked to causes of severe constitutional disorders, the assay provides more actionable information than is obtained with other commonly used methods, yet avoids answers of unknown significance.

Degania Silicone buys Arthesys

Degania Silicone (Degania Bet, Israel) an OEM manufacturer of silicone products for the device industry, reported in May the acquisition of Arthesys (Genevilliers, France), an OEM company that designs a range of cardiovascular catheters and stents.

Tsvi Benayoun, Degania's business development manager, has been appointed as Arthesys' new president, and Pierre Hilaire, the company's founder, will stay on as the company's chief technology officer.

eMix in European distribution accord

eMix (San Diego), the new business venture incubated by DR Systems, reported last month that it has established its first European distributor agreement, with DFC Systems (Munich, Germany).

eMix, which stands for Electronic Medical Information Exchange, enables secure sharing of images and reports among disparate institutions and physicians via the Internet. It also facilitates associating patient images with electronic medical records and patients' personal health records.

TT partners with Hong Kong health association

TT electronics (Weybridge, UK), an electronics manufacturing services provider, says it is continuing its partnership with the Hong Kong Medical & Healthcare Device Industries Association (HKMHDIA), a medical sector think-tank dedicated to promoting bioscience assets throughout Asia and accelerating the growth of a globally competitive bioscience industry.

“Our partnership with the HKMHDIA demonstrates our continued investment and commitment to the global medical device and manufacturing industry,“ said Byron Zhang, managing director of the Suzhou, China facility.

Stockholm hospital to be built by consortium

The Stockholm County Council Assembly decided to award the Public Private Partnership (PPP) project to build the New Karolinska Solna University Hospital (NKS) to a consortium composed of Skanska, a Swedish construction company, and British investment fund Innisfree. A partner in this project is also Coor Service Management, responsible for facility management. The building has been designed by Tengbom architects, based on a design concept created by White architects.

The construction cost for the new university hospital amounts to SEK 14.5 billion ($1.91 billion). The PPP project includes facility management for the operation of the property until 2040, with the option of extending it for a further 15 years.

Construction is expected to start this summer and the hospital expects to admit its first patient n December 2015. The new university hospital will be created to provide healthcare, research and education, in close collaboration with Karolinska Institutet (Stockholm), the medical university, as well as other universities and life science industry in Sweden and abroad.

Endosense enrolls patients in EFFICAS I

Endosense (Geneva, Switzerland), a Swiss medical technology company, reported recently that it has enrolled the first patients in EFFICAS I, the first study of the EFFICAS series. These patients were enrolled in Na Homolce Hospital (Prague, Czech Republic) and treated by Petr Neuzil, MD, and Vivek Reddy, MD.

EFFICAS is a study series intended to demonstrate that the use of contact force control during cardiac ablation using the company's TactiCath force-sensing catheter results in superior outcomes as compared to ablations performed without a force sensor.

EFFICAS I and EFFICAS II are single-arm, multi-center, prospective pilot studies that will assess the effectiveness of catheter ablation with and without the use of contact force control. In EFFICAS I, physicians will perform the procedure with the TactiCath without having access to contact force measurements; however, the contact forces applied will be recorded. In EFFICAS II, physicians will take full advantage of the TactiCath contact force control features, with the ability to objectively influence their ablation technique during lesion creation. The endpoint for EFFICAS I will be the occurrence of reconduction areas in the pulmonary vein isolation (PVI) lines, relative to the contact forces applied; endpoints for EFFICAS II will include reduction in PVI reconduction as compared to EFFICAS I.

Outcomes data from EFFICAS I and II will help in the design of future, larger, EFFICAS studies with clinical endpoints.

The TactiCath force-sensing ablation catheter and the TactiSys system are indicated for the treatment of atrial fibrillation and supraventricular tachycardia. Biotronik is the exclusive distributor of the TactiCath in Europe, Latin America, Canada, Africa and the Middle East. The TactiCath is not yet available in the U.S.

Regulatory approvals in Japan, China, EU

A sampling of last month's regulatory approvals outside the U.S. include:

• Concentric Medical (Mountain View, California) reported that its Merci retriever, Merci microcatheter, and Merci balloon guide catheter have received Shonin approval in Japan. The Merci retriever is a catheter-based medical device that stroke centers use to remove blood clots from the brains of patients suffering an ischemic stroke.

• St. Jude Medical (St. Paul, Minnesota) reported regulatory approval from the Japanese Ministry of Health, Labour and Welfare (MHLW) of its AnalyST implantable cardioverter defibrillator (ICD) with ST monitoring, a device designed to continuously monitor electrical changes to help physicians monitor for cardiac problems. According to the company, the AnalyST ICD with ST monitoring is the industry's first device to continuously monitor specific changes in the heart's electrical system that can indicate conditions such as ischemia (which occurs when the flow of oxygenated blood to the heart muscle is obstructed).

• Boston Scientific (Natick, Massachusetts) said it has received CE mark approval for its Taxus Element Paclitaxel-eluting coronary stent system, the company's third-generation drug-eluting stent technology. This approval includes a specific indication for the treatment of diabetic patients. The Taxus Element stent system incorporates a platinum chromium alloy with an “innovative stent design“ and an advanced catheter delivery system, according to Boston Scientific.

• China Medical Technologies (Beijing) has received approval for its Automaglia 90 fully-automated enhanced chemiluminescence immunoassay analyzer as well as a Down Syndrome Screening kit from the State Food and Drug Administration of China. Automaglia 90 Analyzer is a fully-automated analyzer for immunoassay analysis in various types of diseases and disorders. Applications include thyroid disorders, fertility and infertility disorders, diabetes, infectious diseases and tumor markers.

• Ethicon Endo-Surgery (Cincinnati), a Johnson & Johnson (New Brunswick, New Jersey) business, reported that the Sedasys system, the first computer-assisted personalized sedation system, was granted a CE mark from the European Union for routine colonoscopy and screening of the upper gastrointestinal tract, and Health Canada granted regulatory approval for the Sedasys system for use by healthcare professional teams during routine colonoscopy. The system integrates drug delivery and patient monitoring to enable propofol sedation personalized to each patient's needs.