Facing the prevailing headwinds of the pandemic, the MedTech industry presses on with product innovation and plans for the future. SmartTRAK reports daily on the challenges still ahead, covering all aspects of the Wound Care market, including Advanced Wound Care, Conventional Wound Care, Infection Prevention, Biosurgery, Surgical Matrices, EU and ROW Advanced Dressings and EU Negative Pressure Wound Therapy.
The following is just a small sampling of the Wound Care updates from around the world compiled, reviewed and posted in real time last week by our SmartTRAK analysts. We constantly monitor the worldwide MedTech industry, sifting through the noise to present to our subscribers the most relevant international news, patents, trends, new products, financial data and competitor developments in the global Life Sciences industry.
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- Medtronic*
Medtronic’s US Patent Application “POWERED SURGICAL TACK APPLIER” was published, describing a powered system for surgical tack application for hernia repair. 20210045740
- Interrad*
Interrad’s US Patent Application “SYSTEMS AND METHODS FOR ANCHORING MEDICAL DEVICES “ was published describing an anchor system that includes an anchor device, a tether and an adapter for securing a catheter to a pt using subcutaneous anchors. 20210052857
- 3M*
3M/KCI’s US Patent Application “A SYSTEM FOR MANAGING INSTILLATION THERAPY ON MULTIPLE WOUNDS WITH A SINGLE FLUID SOURCE” was published describing a system structured to administer NPWT and/or instillation therapy to more than one wound site on a patient. 20210052788
- Sealant Applicator
Tissium’s US Patent Application “Applicator For Depositing A Layer Of Adhesive Or Sealant Composition On A Biological And/Or Prosthetic Tissue” was published, describing an applicator to apply an even coat of surgical sealant to bleeding tissue or a surgical matrix. 20210038210
New Products:
- Smith & Nephew*
S+N noted that further regional launches of existing products are planned and that they are working on products specifically for the needs of our second-largest market China. SNN Q420 Earnings Transcript on Seeking Alpha
- Lifotronic
Lifotronic, a manufacturer of medical devices for diagnostic and therapeutic purposes, headquartered in Shenzhen, China, introduced a new NPWT system (NP-800/200). The system reportedly works w/ instillation, has real time vacuum monitoring and has an antibacterial filter system.
- Perceptive Solutions*
Perceptive Solutions announced the release of its real-time patient population Clinical Wound Dashboard. The interactive dashboard reportedly provides an intuitive cockpit view with wound and patient data sets that will help drive more informed wound care decision making.
Studies:
- 3DMAX* - Becton Dickinson*
Surgical Endoscopy published results from a 48-pt study comparing 3DMax and UltraPro hernia meshes in minimally invasive hernia repair. The authors reported similar insertion times for both meshes. - Contraction Of Fibrin Hydrogels
J Biomed Mat Res published results from evaluation of the contraction of various fibrin hydrogels used for skin substitutes. The authors reported temperature-dependent contraction of 40% on average.
- Infection Rates In Suture And Mesh Incisional Hernia Repair JACS published results from a 480-pt RCT comparing suture closure, onlay mesh repair or sublay mesh repair in incisional hernia repair. The authors reported infectious complications were similar between suture and mesh repair, though onlay had a higher infection rate.
Deals/Financing:
- Xtant*
Xtant has closed its previously announced $20MM private placement to a single healthcare-focused institutional investor, selling 8,888,890 common shares and warrants to purchase 6,666,668 common shares at a combined purchase price of $2.25/share.
- MTF*
MTF Biologics has been awarded a group purchasing agreement for Regenerative Skin Tissues w/ Premier, effective 04/01/21, allowing Premier members to take advantage of special pricing & terms pre-negotiated by Premier for MTF Biologics’ portfolio of wound care innovations.
- CollPlant*
CLGN announced it closed a previously announced registered direct offering for purchase & sale of 2.0MM of the Company's ADSs at a price of $17.50/ADS. Net proceeds to be used for gen purposes, and may incl funding the development of regenerative and aesthetic medicine products.
Clinical/Regulatory:
- Potential New Nanofibrous Dressing Material
In Portugal, researchers published a study on a potential double-layer nanofibrous dressing material using polylactic acid (PLLA), chitosan and Hypericum perforatum L. The result strengthens the potential usage of the material for antimicrobial dressing.
- Predictive Technology for DFUs
A 50-pt clinical trial will evaluate a predictive technology using temperature trending for prevention of DFUs w/ primary outcome of monitoring daily temperature changes over 3 months. Not yet recruiting, est study completion is Sept 2021. clinicaltrials.gov - Tactile Medical*
Tactile reported that the company received 510(k) clearance to market its solutions for both lipedema and phlebolymphedema. TCMD Q420/FY20 Earnings Transcript on Seeking Alpha
Announcements:
- Zhende*
Zhende is investing $100MM (CNY 650MM) in a manufacturing facility for protective surgical equipment and surgical instruments and also establishing the Institute of New Medical Biomaterials for research of new biomaterials.
- Zimmer Biomet*
Zimmer Biomet announced the appointment of Sreelakshmi Kolli, Sr VP, Chief Digital Officer of Align Technology to its BoD, bringing expertise that will help the Company in developing integrated digital and robotic technologies that leverage data, machine learning and AI.
- Shandong Wego*
Wego held its 2020 Work Summary meeting. In 2020, 45 new products were approved for marketing. Sales and procurement processes have been approved. The yr 2021 marks the first yr in the new 5-yr plan.
Markets:
- Smith & Nephew*
S+N noted in its earnings call that the 2021 focus of its Adv Wound Mgmt business will aim to build on its recent acquisitions with new versions of GRAFIX and STRAVIX and LEAF, as well as launching the next generation of PICO. SNN Q420 Earnings Transcript on Seeking Alpha
- Diabetes Incidence in Germany
In Germany, the Scientific Institute of the AOK (WIdO) published a new interactive website on 18 major diseases, including diabetes type 1 and type 2. In general, data shows that incidence rates depend heavily on age, gender and place of residence.
- Xtant*
Mgmt noted that XTNT has undertaken numerous strategic and operational initiatives to preserve cash while rightsizing operations, mitigating the effects of the pandemic while positioning focus on delivering growth in the yrs to come. XTNT Q420 Earnings Transcript on Seeking Alpha
Revenues:
- MediWound*
For Q420, MediWound reported $6.7MM, an increase of 23% YoY, of that product revenues totaled $2.8MM, reflecting an increase of 155% in comparison to the fourth quarter of 2019, primarily driven by BARDA emergency stockpile procurement.
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