A BB&T Staff Report

Sunrise Medical (Malasch, Germany) last month reported that it has refinanced its existing senior secured credit facilities with the issuance of a new long-term €90 million ($120 million) senior secured term loan. In connection with the refinancing, the company also reported the official separation of DeVilbiss Healthcare (Somerset, Pennsylvania), its respiratory and sleep therapy division, into an independent company.

Sunrise said the refinancing follows the strongest growth year in its history, with annual growth in earnings before interest, taxes, depreciation and amortization exceeding 100%. Additionally, the company has recently launched four new products including the Q7 custom wheelchair line.

“This financing is an important and exciting step for Sunrise as we continue to execute our strategic growth plans,“ said Thomas Rossnagel, president/CEO of Sunrise. “The refinancing of our senior secured facilities leaves us in a strong financial position to fund growth. This reorganization also allows Sunrise to pursue acquisitions in both Europe and North America.“

Rossnagel added that the refinancing allows the company's European business to become the sole borrower, leaving North America debt-free and fully funded for growth.

DeVilbiss will operate as a separate, independent company, focused on its respiratory and sleep businesses. While DeVilbiss has been operating as a separate division since 2007, the refinancing will allow the company to officially standalone as its own entity with no debt and separate long-term financing.

Existing investors including Vestar Capital Partners and Park Avenue Equity Partners maintain controlling investment interests in both organizations, and will serve on the boards of both companies. Management will also have an ownership stake in the companies.

Sunrise develops manual wheelchairs, power wheelchairs, motorized scooters and both standard and customized seating & positioning systems.

McKesson to sell Asia Pacific unit to Medibank

McKesson (San Francisco) reported in April that it has agreed to sell its Asia Pacific business to Medibank Private, a private health services and insurer in Australia. The acquisition is expected to close in the second calendar quarter of 2010, subject to customary conditions, including regulatory review in Australia.

McKesson Asia Pacific (MAP) is a provider of phone- and web-based healthcare services, including telephone triage, health and wellness advice, chronic disease management and mental health services in Australia and New Zealand. Medibank is an existing MAP customer and offers many complementary services to its customers, McKesson noted.

The transaction is a share purchase, the company said. Financial terms of the sale were not disclosed.

Saladax in Japanese distribution accord

Saladax Biomedical (Bethlehem, Pennsylvania) has executed an exclusive distribution agreement with Falco SD Holdings (Kyoto, Japan) for the Saladax My-5-FU MYCARE test kit in the Japanese market. The My-5-FU blood test enables oncologists to determine the precise amount of 5-fluorouracil (5-FU) chemotherapy in a patient's blood, allowing them to administer an accurate dose to each patient.

Under the terms of the agreement, Falco will pursue Japanese regulatory approval for the distribution and reimbursement of the My-5-FU test, both for sale of test kits and provision of testing services through their reference laboratory. Saladax will supply their My-5-FU kits to FALCO SD for their internal use and distribution to other laboratories.

Biotronik wins approval of ProMRI pacing devices

Biotronik (Berlin) reported winning approval of its new ProMRI pacing systems – Evia pacemaker series and Safio S pacing leads – providing European patients the first portfolio of bradycardia systems that are MRI compatible under specific conditions.

According to the company, the approval of the ProMRI series is the first time an entire pacemaker series, including two single chamber and two dual chamber devices, has been cleared for use in combination with MRI. To gain approval, the Evia pacemakers and Safio S leads were “vigorously tested“ in various combinations of device and lead positions and lengths, scanning time periods, and body positions in the MRI machines, all under strict regulation of the notified body, Biotronik said.

The company noted that its ProMRI portfolio includes four different Evia pacemakers and two different lengths of the Safio S pacing leads. The system was designed and approved for use with MRI under specific conditions.

The company notes that MRI is the gold standard for soft tissue imaging and an invaluable medical diagnostic tool for many common diseases and conditions in the area of oncology, neurology and orthopedic injuries. In 2007, there were roughly 30 million MRI scans conducted in the U.S. alone and that number continues to grow, the company said. Until recently, the two million European patients with an implanted pacemaker were prohibited from receiving MRI scans, because the strong forces applied as part of the MRI scanning could negatively affect the pacemaker system or patients' safety.

With a thin lead body (6.6 F), Safio S are active fixation leads with a flexible distal end, fractal coating and steroid elution to ensure optimal electrical performance and a stable fixation, Biotronik added.

The company also offers continuous remote patient monitoring before and after MRI scanning through its Biotronik Home Monitoring system. Physicians are alerted if there are any clinically relevant changes in their Evia patients' condition or pacemaker status before or after the MRI procedure and have immediate access to all relevant data, the company noted.

Tryton completes enrollment in two studies

Tryton Medical (Durham, North Carolina) said last month it has completed enrollment in two European registry studies, E-Tryton 150 and E-Tryton Benelux, of the company's Side Branch Stent system for the treatment of atherosclerotic lesions in the side branch at the site of a bifurcation.

Tryton says it is conducting various registries in Europe evaluating the Side Branch Stent system in real-world clinical settings. In addition to E-Tryton 150 and E-Tryton Benelux, E-Tryton Spain (TRES) continues to enroll patients. More than 1,000 patients in Europe have been treated with the system so far, the company noted.

“Early data for the Tryton Side Branch Stent system is very promising. The E-Tryton studies will help us understand the use of the Tryton Side Branch Stent system in real-world practice,“ said Pieter Stella, MD, PhD, director of the Heart Catheterization Laboratories and Clinical Cardiovascular Research at the University Medical Centre (Utrecht, the Netherlands), who participated in E-Tryton Benelux.

Areas of bifurcation in the vascular system are a common location for plaque and are particularly challenging to treat with currently available stent systems. As a result, the side branch is often left unstented, leaving it vulnerable to higher rates of restenosis, the re-narrowing of the stented vessel following implantation. Roughly 22% of patients treated for coronary artery disease have diseased bifurcated lesions, according to Tryton.

The E-Tryton 150 study enrolled 151 patients, and E-Tryton Benelux enrolled 155. The primary endpoint of the studies is the overall rate of major adverse cardiac events (MACE) at six months following the procedure. MACE is defined as cardiac death, myocardial infarction and target lesion revascularization (main and/or side branch). The studies will also assess the technical success of the Tryton stent, procedural success, and the rate of target lesion revascularization at six months after the procedure.

Ness in $44M deal to develop EHS in Slovakia

Ness Technologies (Bratislava, Slovakia), a provider of information technology solutions and the leader of a consortium with its partner Lynx (Kosice, Slovakia), said last month it had on a public tender with the Ministry of Health of the Slovak Republic to provide the first phase of an electronic healthcare services system, valued at €32.4 million (about $44 million), excluding VAT. The term of the initial phase is 24 months.

Ness will be responsible for the development of the system software and will serve as system integrator, in work representing €17.8 million (about $24 million) excluding VAT, of the total phase one project budget. Lynx will be responsible for security and infrastructure, representing €14.6 million (about $20 million), excluding VAT, with its partners.

Among other things, the objectives of the phase one implementation are to establish a national health portal to ensure the central provision of public health information to patients, healthcare personnel and external organizations.

JenaValve closes 19M 'B' round for TAVI entry

JenaValve Technology (Munich, Germany), a device company developing transcatheter valve implantation (TAVI) systems, said it has closed on a €19 million Series B round led by two co-lead-investors, VI Partners, Switzerland and Sunstone Capital, Denmark. Gimv NV, Belgium, joined the consortium as a co-investor.

The company says the investment should ensure financing for its transapical and transfemoral systems up until its European market entry.

Existing investors include Edmond de Rothschild Investment Partners, NeoMed Management, and founding investor Atlas Venture.

JenaValve's systems feature the JenaClip stented aortic valve designed to provide accurate placement and the ability to retract and reposition the device if needed for enhanced patient safety.

German companies acquire 50% of VistaMed

The Freudenberg Group and its affiliate Helix Medical Europe (both Kaiserslautern, Germany) have acquired a 50% share of VistaMed (Carrick-on-Shannon; Ireland), a manufacturer of components for medical devices. The two companies say they expect the cooperation to provide synergies in the development of products and services as well as market penetration.

VistaMed has two production facilities in Ireland, where complex medical tubing systems and precision components for medical devices are produced under cleanroom conditions. Examples of applications include catheters for minimally invasive surgical procedures and endoscopic components.

biospace med reports raising $18M

biospace med (Paris) reported in April that it has raised $18 million to accelerate market expansion in North America and Europe of its EOS ultra-low-dose 2-D/3-D imaging system.

The round included existing investors Edmond de Rothschild Investment Partners (Paris), Crédit Agricole Private Equity (Paris), UFG Private Equity (Paris), NBGI Ventures (London), COFA Invest (Paris); and new investor CDC Entreprises, acting on behalf of the SIF (Strategic Investment Fund).

EOS is a medical imaging technique that allows full-body 2-D and 3-D imaging of patients using radiation doses up to 89% lower than those required for a standard CR (computed radiography) X-ray. EOS is designed to reduce irradiation linked to radiological investigations, which has risen by 600% over the past 20 years, the company noted.

Torax wins CE mark for anti-reflux device

Torax Medical (St. Paul, Minnesota) reported in April that it has received a CE mark for its Linx anti-reflux treatment. The company has started commercial launch of the Linx device at select centers in Europe.

According to Torax, the Linx device is a ring of interlinked, miniature titanium beads with magnetic cores. The device is placed around the esophagus just above the stomach using a standard laparoscopic procedure. The design is intended to augment the existing sphincter, preventing it from opening to acid and other reflux. When swallowing, the beads can momentarily separate, allowing food to pass into the stomach; magnetic attraction between beads helps the device to close. Patients are expected to resume normal activities and a normal diet upon discharge.

Oraya awarded CE mark for IRay system

Oraya Therapeutics (Newark, California) said it has received the CE mark for its IRay stereotactic radiotherapy system. Under development since 2007, the IRay is designed specifically to treat diseases of the eye, and the technology enables precise delivery of low energy X-rays for the treatment of wet age-related macular degeneration (AMD), according to Oraya.

Clinical trials for the IRay are now underway in Europe, in the first-ever masked and sham-controlled study intended to demonstrate the efficacy and safety of radiation therapy for the treatment of AMD, the company noted. The one time radiation treatment is given in conjunction with the current standard of care anti-VEGF drug regimen, and with the expectation that visual acuity outcomes for the treated patients will be maintained with significantly less frequent drug injections as compared to the sham controlled group. Oraya said 150 patients from up to 10 sites will participate in the trial with roughly a third of those subjects receiving a sham exposure and the remainder receiving a radiation dose of either 16 or 24 Gray.

KCI reports first Japanese placement of V.A.C.

Kinetic Concepts (KCI; San Antonio) reported the first patient placement of its V.A.C. ATS therapy system in Japan. KCI said the event represented the commercial launch of the therapy in Japan and the beginning of a comprehensive market development strategy in the country.

Kyorin Hospital became the first institution in Japan to use V.A.C. therapy on a patient, who had a pressure ulcer. Typical patients eligible for V.A.C. therapy in Japan include those with dehisced and hard-to-heal open wounds, and wounds following trauma, surgery, amputation and debridement.

Naviscan's PEM available in Columbia

Naviscan (San Diego) said it has received approval from the Colombian Ministry of Health for the commercial introduction of its positron emission mammography (PEM) scanner into Colombia. Naviscan says it makes the only commercially available PEM imaging scanner and PEM-guided biopsy system. The scanner uses PET technology to produce tomographic images that allow physicians to visualize breast tumors down to 2 mm, the width of a grain of rice. The scanner is the size of a mammography unit and uses gentle breast immobilization, allowing for greater patient comfort, as well as reducing motion artifact and improving image resolution, the company said.

USGI gets CE mark for IOP instruments

USGI Medical (USGI; San Clemente, California) reported that European regulatory authorities have granted the CE mark to the instruments that make up its incisionless operating platform (IOP).

The IOP consists of the Transport multi-lumen access platform, the g-Lix Helical endoscopic tissue grasper, the g-Prox grasping/tissue approximation device, and the g-Cath tissue anchor delivery catheters with expandable tissue anchors. Each instrument received individual CE mark certification.

According to USGI, it has developed the first durable suturing system for use in incisionless surgery. The instruments that make up the IOP have previously received 510(k) clearance and have been used in “hundreds“ of incisionless procedures in the U.S., according to the company.

Irvine Scientific kits get CE mark

Irvine Scientific (Santa Ana, California), a developer of in assisted reproductive technology (ART), reported that it received the CE mark for its Vit Kit-Freeze, Vit Kit-Thaw and Oil for Embryo Culture. The regulatory milestone came on the heels of CE mark approval for a number of other media for ART from Irvine Scientific, the company noted.

In December the company received the CE mark for its complete range of culture media and andrology products.

Exactech to start Japanese distribution

Exactech (Gainesville, Florida) said it has received approval to market its Novation primary hip replacement system in Japan.

Japan's Ministry of Health, Labour and Welfare granted Exactech the approval to market elements of the Novation comprehensive hip system, including the tapered femoral hip stem, femoral heads and bi-polar implants. The hip system is designed to provide stability and excellent range of motion for the patient and ease-of-use for the surgeon. The company said it also is pursuing approval for additional components within the product line, to support femoral and acetabular reconstruction.