Inverness Medical Innovations (IMI; Waltham, Massachusetts) has introduced a fourth-generation rapid HIV diagnostic test, the Determine HIV-1/2 Ag/Ab combo, saying it is capable of detecting HIV infections earlier than HIV antibody-only tests. IMI says the test is the first rapid diagnostic enabling simultaneous detection of HIV p24 antigen (Ag) and antibodies (Ab) for HIV-1 and HIV-2 in human serum, plasma or whole blood. The p24 antigen is present during the first few weeks of HIV infection and can be identified before HIV antibodies are produced, making it an ideal marker to aid in early HIV detection. The Determine HIV-1/2 Ag/Ab combo is a rapid, point-of-care lateral flow test which provides clear visual results in 20-minutes. The format enables HIV testing to be conducted in a broad range of clinical settings, from the physician's office to the most remote environments of the developing world.
Innocoll (Ashburn, Virginia) said that the last patient has been dosed in the first of three ongoing phase 2 clinical trials sponsored by its wholly owned subsidiary, Innocoll Technologies, to investigate CollaRx bupivacaine surgical implant for the management of post-operative pain. The implant is a biodegradable, bioresorbable matrix of purified fibrillar collagen impregnated with the local anesthetic bupivacaine, formulated using Innocoll's CollaRx sponge technology. The implant is intended to provide pain control at the surgical site. The collagen matrix biodegrades over a few days and the bupivacaine is released to provide local analgesia for up to 96 hours post-operatively. Innocoll said that an important feature of the technology is its ability to be implanted directly into the surgical cavity and at different layers within the wound, such as across the peritoneal incision and directly below the skin incision, enabling localized treatment of both the incisional and deep, visceral pain components associated with moderate and major surgery. Innocoll is a developer of biodegradable surgical implants and topically applied healthcare products.
KLS Martin (Jacksonville, Florida) reported the implantation in the 500th patient of the Sternal Talon, an alternative method of closure for midline sternotomies used in many heart procedures, and using rigid orthopedic-style fixation. Originally developed as a reconstructive alternative for patients with sternal instability and non-unions, the Sternal Talon has been used in primary closure for patients undergoing midline sternotomy for coronary artery bypass graft and valvular surgery, KLS said. It said that many of these 500 patients had multiple co-morbidities which may lead to infections that can be fatal. Until recently the cardiothoracic surgeon had few treatment options for these patients, KLS said. KLS develops craniomaxillofacial and sternal fixation technologies.
Vapotherm (Stevensville, Maryland) reported receiving FDA clearance for Precision Flow, its high flow humidification system used to integrate gas blending, flow control and humidification technology into one device for the conditioning of nasal cannula inspired gases. Vapotherm said that Precision Flow was made with input from professionals in neonatology, pediatrics and adult respiratory care, the resulting system combining that safety and ease of use.