BoneSupport expands sales team

BoneSupport today announced plans to expand its sales force, adding an additional 13 sales representatives in “key markets” this year.

The Swedish company said that the objective of the expansion is to increase the market penetration of its antibiotic-eluting Cerament G and Cerament V products.

BoneSupport touted that in April, three studies of its Cerament platform were presented at the British Limb Reconstruction Society meeting, some of which showed improved bone healing and reduced risk of recurrent infections with the use of the Cerament G product.

“Cerament G and V have strong sales momentum in Europe due to their increased use in a wide range of orthopedic indications. The adoption level is particularly high in osteomyelitis, a challenging indication that generally requires repeated surgical interventions. We see significant commercial potential for Cerament G and V in multiple important treatment areas, including the much larger trauma indication. Today’s decision to almost double the number of sales specialists in Europe, reflects the sizeable opportunity we see for our Cerament products across the region in indications where we have so far had a relatively low level of penetration,” CEO Emil Billbäck said in a press release.

Earlier this month, BoneSupport said it inked a strategic agreement with Collagen Matrix to expand its product offering to the U.S.

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7 medtech stories we missed this week: May 25, 2018

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From Mauna Kea receiving FDA clearance to Medacta getting clearance for its pedicle screw placement guide, here are seven medtech stories we missed this week but thought were still worth mentioning.

1. Mauna Kea wins FDA nod for neurosurgery indication

Mauna Kea announced in a May 24 press release that it has received FDA 510(k) clearance for its Celivizio 100 series F400 and F800 with new Confocal Miniprobe, the CranioFlex. The clearance allows the device to be used during neurosurgical procedures. The Cellvizio 100 with CranioFlex gives allows for imaging of tissue internal microstructures and allows for identification of cells and vessels and their organization in the central nervous system during cranial diagnostic and therapeutic procedures. The F400 series operates at 488 nm and the F800 model operates at 800 nm.

2. Bonesupport, Collagen Matrix ink deal

Bonesupport has signed a strategic agreement with Collagen Matrix to expand its product offering to the U.S., according to a May 24 press release. The agreement states that Bonesupport will start selling and marketing some of the Collagen Matrix bone graft substitute products under its own brand and through its own distribution network in the fourth quarter of this year.

3. Implanet launches Jazz Evo spine implant

Implanet announced in a May 23 press release that it has launched its Jazz Evo implant that is designed to respond to the constraints of vertebral fusion indications in adults. The implant is designed to facilitate the treatment of degenerative pathologies in adults and is part of the company’s Jazz range of products that block the braid with a single screw to ensure optimum clamping on the rod without damaging the braid.

4. MC10 wins FDA nod for BioStamp nPoint wireless patient monitor

MC10 recently received FDA 510(k) clearance for its BioStamp nPoint System, according to a May 16 press release. The system is a wireless, biometric data collection platform that is designed to be used by healthcare professionals and researchers for collecting physiological data continuously in the home or in traditional healthcare settings. It is specifically designed for clinical trials or research studies where continuous collective data is needed. It features flexible, body-conforming rechargeable sensor patches that are reusable and can record data for up to 24 hours. It can be configured to measure, record and display general activity, postural classifications, vital signs and sleep metric with clinical validated accuracy.

5. FDA clears second XableCath peripheral catheter

XableCath announced in a May 24 press release that it has received FDA clearance for its XableCath abrasion tip support catheter. This clearance marks the second clearance for the company after its blunt tip catheter was cleared at the end of 2017. Both XableCath’s designs are designed to easily slide past occluding atheroma through the true lumen of the vessel.

6. CrossRoads Extremity Systems launches DynaForce foot implant

CrossRoads Extremity Systems has launched its Active Stabilization MPJ Implant System, according to a May 22 press release. The company launched the product after it received FDA clearance for its DynaForce system. The DynaForce Active Stabilization MPJ Implant System combines stability and an anatomic plate with active compression of a nitinol clip that is delivered to the operating room in a sterile package.

7. FDA clears Medacta pedicle screw guide

Medacta announced in a May 23 press release that it has received FDA clearance for its MySpine Midline Cortical Pedicle Screw Placement Guide. The MySpine MC system allows surgeons to optimize procedures for both outpatient and inpatient settings for a more rapid patient recovery through accurate and reliable muscle-sparing approaches to posterior lumbar surgery. The system guides the screw to a trajectory in the pedicle that has evolved from a cortical bone trajectory. The system also avoids interference with cranial facet joins and can accommodate larger screw diameters and lengths with four points of cortical bone purchase.

The post 7 medtech stories we missed this week: May 25, 2018 appeared first on MassDevice.

7 medtech stories we missed this week: March 24, 2017

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From companies receiving CE marking to other companies adjusting their distribution deals, here are 7 medtech stories we missed this week but thought were still worth mentioning.

1. Viveve Medical closes public offering

Viveve Medical announced that it closed its underwritten public offering of 8,625,00 shares of its common stock, according to a March 22 news release. The public offering price was $4 per share, and the company estimates that the net proceeds from the offering will be nearly $31.7 million after deducting underwriting discounts and commissions.

2. Masimo receives CE Mark for Rad-97 Pulse CO-Oximeter

Masimo announced that it received CE Marking for its noninvasive blood pressure measurements from its Rad-97 Pulse CO-Oxumeter and connectivity hub, according to a March 20 news release. Rad-97 allows clinicians to measure arterial blood pressure in adults, pediatric and neonatal patients. It measures using 3 measurement modes: spot-check, automatic interval and stat interval. The built-in port lets clinicians connect a blood pressure cuff inflation hose right on the Rad-97. It also enables easy and automatic charting of blood pressure data directly from the same monitoring device that measures oxygen saturation, total hemoglobin and other noninvasive parameters. The device has WiFi and Bluetooth connectivity that allows the device to connect to other devices that are nearby. With its user-friendly multi-touch navigation, clinicians can customize the high-resolution, 1080p HD color display to what they need.

3. Glaukos announces reimbursement win

The opthalmic medical technology company Glaukos Corp. has announced that the Current Procedural Terminology (CPT) Editorial Panel of the American Medical Association has given it a 5-year extension to 3 Category III CPT codes that describe insertion of aqueous drainage devices into the anterior chamber of the eye during micro-invasive glaucoma surgery, according to a March 16 news release. Physicians and other healthcare providers use CPT codes to report and receive Medicare reimbursement for services. The 3 CPT codes that received an extension are 0191T, 0253T and 0376T, all of which deal with the iStent device.

4. DiamiR wins $2.75 million grant for Alzheimer’s biomarker diagnostic device

DiamiR announced in a March 15 news release that it was awarded a $2.75 million Small Business Innovation Research (SBIR) Phase IIB grant from the National Institute on Aging and the National Institutes of Health. The grant is going toward supporting the development of DiamiR’s targeted diagnostic technology that analyzes brain-enriched microENA biomarkers in plasma to detect Alzheimer’s disease. The grant will stretch over a 3 year period and builds on to the company’s earlier studies that received SBIR Phase I and SBIR Phase II grants.

5. Flowonix and Cerebral Therapeutics launch clinical trial

Flowonix and Cerebral Therapeutics announced that the first patients of its clinical trial have had the Prometra implanted, according to a March 14 news release. The clinical trial, called ADDRESS, is the first multi-center dose ranging clinical study that evaluates intracerebroventricular (ICV) delivery of the drug valproate in patients who have focal seizures and have a temporal lob onset with to without secondary generalization. The study includes 9 patients who will undergo this treatment and will receive the valproate from the Flowonix Prometra II Programmable Pump.

6. Bonesupport extends U.S. bone Cerament distribution deal

Bonesupport has extended the terms of its U.S. distribution agreement with Zimmer Biomet, according to a March 14 news release. Zimmer Biomet will continue to have exclusive rights to Sonesupport’s Cerament Bone Void Filler designed for orthopedics, trauma and foot and ankle indications in the U.S.

7. Ortho Clinical Diagnostics and Astute Medical extend partnership

Ortho Clinical Diagnostics has expanded its agreement with Astute Medical for its NephroCheck Test distribution, according to a March 13 news release. The NephroCheck Test is a biomarker-based test that asses the risk for acute kidney injury. This new agreement gives Ortho Clinical Diagnostics the distribution rights in more European countries. Astute Medical gave Ortho a license to develop and market the NephroCheck Test in the U.S. and certain countries in Europe in 2014.

Here’s what we missed last week.