Aerin Medical is developing novel therapies to improve nasal breathing and reduce rhinitis. Aerin's products are applied to locations in the nasal passage responsible for the majority of resistance to nasal airflow and the collection of cells primarily responsible for over production of mucous. The tremendous advantage of Aerin's treatments compared to surgery are that they are very quick, non-invasive, have essentially no recovery time, and can be performed in a physician's office.
Each year, millions of people in the United States will require central venous access for the delivery of dialysis or nutrition, for intravenous chemotherapy, or for the placement of a cardiac pacemaker. It is estimated that more than 40% of these patients will experience venous obstructions that compromise their treatment.
Bluegrass Vascular Technologies, Inc. (BVT) is developing a unique lifesaving device that redefines the standard of care for central venous access procedures: The Surfacer™ Inside-Out Access Catheter System is a novel approach to gaining central venous access by inserting a guide wire through the femoral vein and navigating it through the body and exiting at the jugular or subclavian vein.
For patients with limited, diminishing or complicated upper body access, the Surfacer™ Access System is designed to provide reliable, repeatable access with fewer complications than other, more invasive, alternatives. BVT is redefining a new standard of care for venous access.
BiO2 Medical, Inc. is a medical device manufacturer founded to design, develop, and subsequently manufacture a range of medical products in response to clinical needs.
BiO2 Medical's current primary objective is to develop and commercialize the Angel™ Catheter as the de facto standard of care device for the prevention of Pulmonary Embolism related mortality and morbidity in critically ill patients worldwide.
This proven team of technical staff is supported by management and advisors who have worked together for 10 years and have extensive experience in: medical device development, product commercialization, and patent portfolio creation.
In July 2016, BiO2 Medical was granted FDA approval for the Angel™ Catheter; the only productapproved for the prevention of pulmonary embolism in hospitalized patients.
BioDtech, Inc. (BDTI) offers new technologically superior products for the bioresearch and bioprocess markets, which are designed exclusively for the detection, neutralization and removal of endotoxin.
Current endotoxin assays accepted by the FDA and pharmacopeias worldwide are based on Limulus (horseshoe crab) amebocyte lysate (LAL) clotting in response to endotoxin. This assay lacks specificity and requires specific conditions for a delicate enzymatic reaction to occur. To circumvent these problems, the molecular site where endotoxin binds to Factor C enzyme to initiate the LAL clotting reaction (the sushi domain) has been identified and patented, and is made chemically rather than extracting from the horseshoe crab. This is the basis for BDTI's proprietary technology for the detection, neutralization and removal of endotoxin.
BioDtech's products address all of the concerns of the endotoxin market and will eliminate common critical issues associated with current methods. Using their reagents, the customer can design assays that are user friendly, yield rapid results that are quantitative and specific to endotoxin contamination without expensive training or equipment. Their products offer the scientist the ability to eliminate the effects of endotoxin contamination by neutralization and/or removal.
Cardiovate is a medical technology company that targets transformational health care opportunities in tissue regeneration and repair through the development of novel products that utilize proprietary materials and processes along with a deep understanding of clinical needs. The Cardiovate scaffold promotes the patient’s own cells to organize into a viable tissue after implantation for repair or replacement of damaged and diseased vasculature.
Cytocentrics is the world leader in the field of high-throughput, high-accuracy cellular patch clamp testing. Cytocentrics' robotic, networked instrument utilizes a unique 3D silicon microfluidics chip to capture and repeatedly evaluate individual cells. Patch clamping is a technique for measuring microscopic voltage changes caused by the movement of molecules through the membrane ion channels of a cel, a function that is central to cellular physiology and drug-cell interactions.
By automating a process that previously could only be conducted by highly trained scientists using laborious manual methods, Cytocentrics is opening up new avenues of research in the field of drug development, neuroscience, diabetes and personalized medicine.
DNAtrix is a Texas-based biotechnology company founded by world-class physicians and scientists from the UCSF Helen Diller Comprehensive Cancer Center and MD Anderson Cancer Center. DNAtrix, Inc. is focused on the development of oncolytic virus technology for the treatment of cancer. DNAtrix’s lead product, delta24-RGD, is a next-generation adenovirus invented by company founders Dr. Juan Fueyo and Dr. Frank McCormick, and is designed to destroy cancer cells without harming normal tissue.
It is hoped that this therapy can be added to the arsenal of surgery, radiation and chemotherapy for the treatment of a variety of tumors. The company launched its first human clinical trials in 2009 at the MD Anderson Cancer Center for the treatment of brain cancer. In 2016, DNAtrix was awarded both EU Orphan Medicine Designation and EMA Prime Designation, an initiative designed to accelerate approval of breakthrough therapies that target an unmet medical need.
ENTrigue Surgical, Inc. designs, develops, manufactures, and distributes instruments, materials, and medical devices primarily for sinus surgery. It offers Ventera Sinus Dilation System, an alternative to other balloon dilation systems; ENTact Septal Stapler, a systems that supplants the need to suture; Synaero Hemostatic Gel, a surface-acting alternative to nasal packing and space-occupying gel that controls mild to moderate bleeding without expanding; and SerpENT Articulating Instruments, which enable surgeons to reach around corners and perform precise dissection.
The company also provides an MediENT Middle Turbinate Implant, a resorbable implant that anchors the middle turbinate to the septum.
Acquired 2013 (Smith & Nephew)
Innovative Trauma Care™ is addressing unmet needs in the field of emergency medicine by developing, manufacturing, and commercializing point of injury solutions to treat common causes of preventable death in traumatic injury scenarios.
ITC launched its first product, The ITClamp™ in 2013.
The ITClamp addresses massive hemorrhage – a leading cause of death in traumatic injury – by controlling critical bleeding in under 5 seconds. The clamping device works by sealing the skin closed to create a temporary pool of blood under pressure, which forms a stable clot until the wound can be surgically repaired. Incorporated in 2010 and based in Edmonton, Canada, ITC recently established its US headquarters in San Antonio, TX.
NeoSurgical is an emerging, award-winning global medical device company focused on providing technical innovation to the surgical devices industry, particularly for those surgeons conducting laparoscopic and minimally invasive surgery (MIS). The companies neoClose® Trocar Port Closure System received FDA approval in 2013 and brings a simple, intuitive, and reliable solution to assist the surgeon in closing port site defects following laparoscopic abdominal surgery.
This device is positioned to change the standard of care in port site closure while helping minimize port site pain and herniation, two potential clinical consequences of surgery that create significant issues for both patients and surgeons.
Roxy’s Remedies, Inc. is a new brand of natural luxury grooming products for dogs with canine atopic dermatitis (CAD), which is the 2nd most common allergic skin disease, affecting an estimated 10% of the 78 millions dogs in the US. Itching caused by allergic skin diseases can be an acute, short-term condition or can be recurrent or chronic and can impact the quality of life for both the dog and its owner unless controlled with effective management. Few natural solutions exist for pet owners seeking pure, safe and effective products to relieve symptoms.
Founded by Marianne Cronin and Vito San Filippo, Roxy’s Remedies was spun off from Santalis Pharmaceuticals and positioned as a new brand of natural, luxury grooming products for dogs with itchy, irritated and sensitive skin. Each product in the Roxy’s Remedies line is formulated with sustainably cultivated, pharmaceutical grade East Indian Sandalwood Oil (EISO) produced by TFS Corporation Ltd. (ASX:TFS) (Santalis was acquired by TFS in June 2015). EISO is a natural, calming ingredient that has been used extensively as a traditional skin healing agent and is being developed by Santalis as a prescription drug for human skin conditions.
With its innovative formulas and true passion for helping dogs everywhere, Roxy’s Remedies is the natural choice in grooming and skin care for dogs.
Soluble Bioscience, LLC seeks to enhance the drug discovery process by rapidly optimizing protein solubility and stability.
Founded in 2008 in Birmingham, Alabama, Soluble Bioscience, LLC was formed to commercialize the HSCTM Technology. This system will enhance and speed the research, development and production of protein-based therapeutics, vaccines and research tools that will improve the quality of life and overall state of public health.
Soluble works with major leading global pharmaceutical companies and leading CROs to significantly reduce the time and costs required to solubalize proteins for their drug development, vaccine and biotech programs.
Acquired 2016 (Cytocentrics)
Santalis Pharmaceuticals, Inc. is a joint venture with TFS Corporation of Australia (ASX: TFC), the world's leader in sustainable sandalwood oil (EISO) supply. TFS has granted Santalis worldwide exclusive rights to ESIO for healthcare use and the company is leveraging this high value botanical drug candidate to develop a unique, evidence-based platform of highly differentiated retail, OTC and Rx botanical healthcare products.
Areas of research and clinical interest include acne, rosacea, eczema, skin cancer and drug resistant infections such as MRSA and Clostridium difficule. Santalis launched its first range of OTC acne products in late 2015, in the US under Galderma's Benzac® Brand.
Acquired 2016 (Quintis Ltd)
ViroXis Corporation, Inc., (San Antonio, TX) is a mid-stage drug development company formed around the in-licensing of a clinical stage drug candidate that contains a well characterized botanical extract. ViroXis Corporation is developing a unique range of patented, effective, and very well tolerated botanical anti-viral topical prescription drug candidates to treat diseases of the skin, such as HPV (skin and genital warts), Pox virus (Molluscum contagiosum), and Herpes (cold sores and shingles).
The company's drug candidates are being developed under the FDA's 2004 botanical guidelines, with a lead product for common HPV skin warts in an FDA Phase 2 study, with a Phase 2 study for Molluscum contagiousum to begin mid 2014.
Acquired 2017 (Quintis Ltd)
StemBioSys is a stem cell therapeutics development company using novel, patented extracellular matrix technology to provide proprietary stems cells for collaborative and in-house therapeutic solutions.
The extracellular matrix (ECM) technology pioneered by StemBioSys enables the clinician to obtain and greatly multiply human non-embryonic stem cells that exhibit a very high degree of potency.
The ECM is a 3D matrix laid down by bone marrow cells that is similar to the native environment of stem cells and can enable the production of significantly more cells of higher quality than existing methodology.
The StemBioSys team is greatly augmented by the addition of Dr. Robert Langer, MIT Professor, as a director and as Chair of the Scientific Advisory Board. Dr. Langer’s lab at MIT is the largest biomedical engineering lab in the world, and he is one of the most widely referenced and awarded engineers alive today.
Vidacare Corporation, Inc. is the developer of a broad technology platform that is defining the field of intraosseous medicine with products indicated for applications including vascular access, emergency and disaster medicine, oncology and spinal surgery.
Established in 2001, Vidacare Corporation, Inc. is the developer of a broad technology platform that is defining the field of intraosseous (inside the bone) medicine.
Current applications include vascular access, emergency and disaster medicine, oncology and spinal surgery. Vidacare's focus on enhancing clinical efficacy, patient safety and comfort, and reducing complications and their associated costs, has resulted in its devices becoming the recognized technology standard. Privately held, the company is based in San Antonio, Texas, and its products are marketed in over 50 countries worldwide.
Vidacare was aquired by Teleflex (NYSE:TFX) in December 2013.
Acquired 2013 (Teleflex)
Xenex Disinfection Services is the world leader in UV room disinfection systems for healthcare facilities. The Xenex room disinfection "robot" can disinfect a room in minutes and is easily portable, allowing it to be used in virtually any location within a hospital. Nearly 200 hospitals and Veterans Affairs (VA) facilities in the U.S. are using the Xenex system, which has proven to be 20 times more effective than standard chemical cleaning practices and credited for helping healthcare facilities in the U.S. decrease their MRSA and C.diff infection rates by more than 50 percent, according to published studies.
3D’s Spline-Fix™ External Fixator System is the only known system of its kind with independent pin placement on a multi-pin clamp. It is capable of treating a variety of different fractures and was developed to address the shortcomings of existing fixators that are more limited in application. The Spline-Fix™ has the flexibility of treating a wide range of fractures throughout the body in both the trauma and limb reconstruction market. The device, made of titanium and applicable for long-bone and small-bone fractures, is based upon a ball collet pin clamp design that features a lengthening transport component which can be lengthened or shortened.
The Spline-Fix™ External Fixator provides unique versatility for the surgeon (independent pin placement on a multi-pin clamp), and is cost effective, strong, simple and easy to use. With its intuitive, light weight titanium construction, the Sline-Fix™ can undergo an MRI scan, which increases and is patient friendliness and clinical utility. It is classified as a Class II medical device and is currently undergoing the 510(k) regulatory process.