Q2 Emerging Medical Technologies Report

Published January 2011 | 137 Pages | 115 Exhibits |

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Overview

This report includes details on 115 companies that: presented at LSI's Q2 2011 Emerging Medical Technologies Spotlight meeting or have been identified by LSI's in-house research team in Q2 2011.

All companies include technology, market(s), key executive, and contact information.

Two- to three-page executive summaries are provided on some of the companies. Executive summaries typically include:

• Company Contact Information
• Company Overview (structure, size, year founded, etc.)
• Competitive Landscape
• Technological Advantage
• Stage of Development
• Target Markets
• Financial Summary and Sales Forecasts
• Financing & Partnering Needs
• IP Position & Status
• Management Team
• Exit Strategy
• More

Coverage includes innovations in a broad spectrum of medical technology areas including:
- 4 Aesthetics/Dermatology Companies
- 22 Biomaterials Companies
- 13 Biotechnology/Cell Therapy Companies
- 20 Cardiovascular Companies
- 3 Dental Companies
- 31 Diagnostics Companies
- 9 Drug Delivery Companies
- 9 Endocrine Companies
- 14 Gastroenterology Companies
- 6 Gynecology/Women's Health Companies
- 17 Imaging Companies
- 23 Neurology Companies
- 13 Oncology Companies
- 3 Ophthalmology Companies
- 12 Orthopedics Companies
- 6 Pain Management Companies
- 20 Patient Monitoring/Management Companies
- 5 Respiratory Companies
- 7 Spine Companies
- 17 Surgery Companies
- 12 Urology Companies
- 19 Vascular Companies
- 8 Wound Management Companies

This report is included in LSI's Emerging Medical Technologies® Database.

Table of Contents

BRIEF TECHNOLOGY DESCRIPTIONS FOR COMPANIES COVERED

• 1-Novel 510(k)-cleared XCOIL(TM) mechanical thrombectomy device initially targeting DVT and stroke patients and 2-Novel 510(k)-cleared EViTAR(TM) double-lumen, coaxial neurocatheters for intracranial delivery of small molecules, biologics, stem cells/gene-based therapies, and smart sensor enhancements
• A "smart shirt" that can count a patient's heartbeats through its sensors, record a medical quality electrocardiogram (ECG), and detect the respiration rate, body temperature, and position of the patient (standing, walking, lying, asleep, or fallen)
• A disposable skin patch that provides diabetics with a painless, BLOODLESS, easy-to-use, and rapid method for monitoring glucose levels
• A disposable, flexible conduit that provides a protective channel through which an endoscope is inserted for sinus surgery, to keep the introduction site open throughout the course of the procedure, thereby minimizing trauma along the nasal passageway
• A low-cost, clip-on eye-piece for mobile phones that mimics and replaces the expensive laser-based Shack-Hartmann wavefront aberrometers to diagnose the most common refractive eye disorders: myopia (nearsightedness), hypermetropia (farsightedness), astigmatism, and presbyopia (age-related visual impairment)
• A minimally invasive implantable pulse generator (IPG) to treat obese and type II diabetics by applying electrical stimulation to the duodenum
• A non-invasive optical brain monitor for monitoring depth of anesthesia and level of sedation via direct measurement of deoxyhemoglobin and hemodynamic response
• A novel suite of workflow tools that automate the viewing, analysis, and interpretation of x-rays for musculoskeletal disease
• A Percutaneous Tracheostomy (PT) system that simplifies the traditional PT technique to be used by more physicians OUTSIDE of the Operating Room (OR) and in faster times than current devices
• A scalable molecular diagnostic chip platform that will allow for the diagnosis of diseases in five minutes as well as in-home monitoring of conditions such as: profound venous thrombosis, embolisms, and myocardial infarctions (MI)
• A unique permanent injectable bulking agent for the endoscopic treatment of GERD (chronic heartburn)
• A unique, high-resolution, and MRI-compatible deep brain stimulation (DBS) system comprising implants with navigation and steering software to treat Parkinson's disease (PD)
• Accurate, ultra-low-cost whole genome sequencing by way of a simple, single-molecule detection process
• Aerosol technology which efficiently delivers therapeutics into the abdominal cavity of patients during surgery to combat post-surgical complications such as pain and adhesions
• Anti-infectives for the treatment of severe infectious diseases
• Artificial sphincter device for use in ostomy and stoma care
• Balloon dilatation catheters capable of completing an angioplasty, fluid delivery, and thrombectomy without changing catheters
• Biocompatible surgical mesh with high tensile stiffness and strength, similar to native tendon, that is sutured over torn or degenerative tissue as a reinforcement to surgical repair to allow for rapid tissue in-growth
• Biodegradable, inflatable balloon device which separates healthy organs from adjacent tumors receiving radiation therapy
• Biologically-active plastic surgical patch for rotator cuff and tendon injuries, designed to promote healing and formation of new bone
• Bioseparation technology, for use outside of the research lab, with broad applications from molecular diagnostics to transplant therapies
• Cardiac mapping catheters to analyze electrical heart activity for the diagnosis of cardiac arrhythmias
• Catheter-based drug delivery system for the treatment of vascular disease and restenosis
• Cost-effective lab-on-a-chip system that anyone can use to get laboratory quality results in any location, within minutes, and with minimal training
• Customized Sound Therapy (CST) system for tinnitus therapy
• Device for the intra-ocular delivery of photoactive nanoparticles for the treatment and prevention of macular degeneration
• Device that increases the size of skin grafts without the use of chemicals, biologics, or enzymes
• Device that uses localized vibrations to reduce pain during injections
• Devices that facilitate minimally invasive access to a beating human heart and the delivery of therapeutic options intended to treat complex cardiovascular diseases
• Disposable device for the prevention of catheter-related infections from hemodialysis
• DNA-testing platform that enables results from a wide variety of gene signatures to be delivered quickly, simply, and cost-effectively at the point-of-care (POC) within an hour
• Drug therapy by way of modulating the N-methyl-D-aspartic acid receptor for the treatment of depression and other central nervous system disorders
• Drug therapy focusing on the carotid body for the treatment of sleep-related breathing disorders
• Eye-tracking device for earlier diagnosis of Parkinson's disease and other neurological diseases
• Femoral vascular access catheter that uses a longer and shallower angle arteriotomy, providing better site closure WITHOUT vascular closure implants
• Flexible endoscopy and endoluminal surgery device
• Full Sense(TM) Bariatric Device which is implanted and extracted via endoscopy and causes satiety leading to weight loss
• Genomics-based diagnostic tests for obstructive coronary artery disease (CAD), cardiac arrhythmias, and heart failure (HF)
• Growth factor, stem cell, scaffold, and bioadhesive technologies that improve the body's ability to regenerate healthy cartilage, improve joint function, and prevent degenerative disease
• Hand-held ultrasound tool that displays a see-through image in the medical practitioners line of sight, at the patients skin surface
• Headset that detects and records brainwaves for the diagnosis of Alzheimer's disease and other neurological disorders
• High-intensity ultrasound energy for non-invasive reduction of arterial plaque
• High-stability, short-length expandable implants that eliminate the need for complex bone augmentation - shortening overall time to implantation and significantly lowering treatment costs
• ImagistxProstate(R), a breakthrough prostate imaging technology providing a diagnostic tool to identify prostate cancer via its 21 MhZ center frequency, 512 element array, and 3D ultrasound capabilities
• Immediate and permanent contraception implant for women to use as an alternative to surgical tubal ligation
• Implantable artificial pancreas for the treatment of patients with Type I & Type II diabetes
• Implantable device consisting of a series of miniature magnetic beads, linked together to form a "bracelet" around the Lower Esophageal Sphincter (LES) for the treatment of gastroesophageal reflux disease (GERD)
• Implantable electronic gastric stimulation device for the treatment of obesity
• In vivo optical imaging devices for real-time diagnosis in a broad range of applications
• Infection control technology that does something no other product can - protect and disinfect BOTH the needleless injection site and the end of the IV tubing male luer
• Intelligent continuous glucose monitoring device utilizing recent innovations in microneedle and bluetooth technology, to provide a more accurate and pain-free method than what current devices offer
• Interwoven biopolymer 3D-oriented matrices that more accurately mimic natural extra cellular matrix (ECM) for use in cell and tissue engineering applications
• Irrigation devices for improved visualization during upper and lower gastrointestinal (GI) procedures
• KeyHole Cup(R) is designed to provide a safer and efficient entry into the abdominal cavity during laparoscopic surgery. It allows for a more rapid insufflation than standard techniques, mitigating associated risks.
• Mammary Aspirate Specimen Cytology Test (MASCT System(TM)) that collects a small amount of nipple aspirate fluid (NAF) in 10 minutes, using no radiation and is painless
• Medical devices for the treatment of neurovascular conditions
• Microcatheters for treating and preventing acute ischemic stroke
• Minimally invasive devices using radiofrequency (RF) energy for the treatment of gastroesophageal reflux disease (GERD) and fecal incontinence (FI)
• Minimally invasive system for decompressing pinched nerves in the spine, based on highly maneuverable tools and a precise tissue-removal mechanism
• Neurocatheter for the removal of blood clots in the brain
• New embolotherapy catheter that minimizes reflux when administering medication
• Next generation X-ray scintillator device that provides high resolution imaging
• Next-generation insulin analogs for both the rapid-acting and long-acting insulin markets
• Next-generation quantitative angiography
• Nicotinic receptor agonist compounds for the treatment of asthma and other inflammatory respiratory and non-respiratory diseases
• Non-invasive hand-held device that detects abnormal heart sounds and uses a smart-phone interface for the diagnosis of coronary artery disease (CAD)
• Non-invasive Auto-Targeting Neurostimulation (ATN) device for high-stimulation pinpoint treatment of lower back pain
• Non-invasive imaging capsule for colon cancer screening
• Non-invasive imaging system for the early detection of pre-cancerous tissue and to guide early treatment intervention
• Non-invasive real-time diagnostic tools for early detection, prevention, and management of Acute Kidney Injury (AKI) in critical care environments
• Non-invasive system for the treatment of acute ischemic stroke and other vascular disorders using externally applied ultrasound that can be rapidly and easily deployed by virtually any emergency room staff
• Non-invasive tumor ablation and incisionless surgery using high-intensity ultrasound
• Non-surgical, removable hearing device that transmits sound through the teeth for the treatment of single-sided deafness
• Novel solutions for wound closure
• Optical Ultrasound Tomography(R) (OUT) is a patented technology that identifies brain injuries, brain hematomas, malignant breast cancers, and Inflammatory Breast Cancer safely and quickly and displays 3D images in "real time" and can transmit the images to waiting hospitals and surgeons. The cameras are lightweight and portable, and can be mounted on a bedside providing continuous monitoring of hemorrhages and the flow of blood. They can be used in an ambulance, on the battlefield, on the Little League field, and in the ER.
• Orthopedic implants for limb lengthening/correction/reconstruction
• Permeable, micro-porous, flexible, and user-friendly implants in tubular or patch shape for bone reconstruction and fracture repair in surgical procedures
• Point-of-care diagnostic tests for infectious diseases capable of detecting virulence markers produced only during ACTIVE infections
• Portable, non-invasive device designed to offer transcutaneous pulsed electro-magnetic field stimulation therapy for treating post-operative pain and inflammation in superficial soft tissue
• Portable, patch-based device that delivers "slow release" ultrasound to treat localized pain and induce soft tissue healing
• Portable/mobile nuclear cardiology imaging system
• Professional and home use devices for automated bladder assessment incorporating a novel, extremely compact, 3D ultrasound scan head and embedded image processing technology
• Proven patented technology platform that rapidly and accurately measures oxidative stress and oxidizability in blood and other biologic fluids, with multiple diagnostic applications
• Real-time pathology solution for cancer surgical guide, with microchip-based in vivo imaging systems
• Removable adhesion barriers for spinal, tendon, and nerve-related surgery to reduce post-operative scarring, pain, numbness, muscles weakness or limited motion
• Revolutionary HyperQ technology based on advanced signal processing of the high frequency ECG signal, enabling more accurate results in the initial diagnosis of coronary artery disease
• Revolutionary raman-spectroscopy based platform technology licensed from the BC Cancer Agency to aid in the early detection of cancer
• Robotic and manual endoscopy devices for increased ergonomics during laparoscopic surgery
• Shape memory implants that restore motion and eliminate pain for patients requiring soft tissue repair, fracture fixation, or joint fusion
• Single-use devices that will address epicardial access, protection, and treatment facilitating the electrophysiologist's ability to perform cardiac ablations more efficiently and with a higher degree of safety and effectiveness
• Single-use needle-free injection system for liquid medications
• Smart-phone based ultrasound imaging system
• Soft, flexible devices with tissue-like characteristics that can be used in cardiology and neurology to make surgical diagnosis and treatment easier - based on a new generation of thin, conformal electronics technology that endures bending, twisting, and stretching without sacrificing performance
• Spinal probe that uses radiofrequency (RF) ablation on nerves thought to be the cause of chronic back pain
• Sternal closure system that maintains rigid fixation of the sternum in multiple directions of force and eliminates the common causes of sternal dehiscence
• Surgical instruments, medical lasers, and other medical devices
• System for the diagnosis and location of stroke, vasospasm, AVMs, aneurysms, and other brain disorders within minutes, including differentiation of ischemic and hemorrhagic stroke
• System that cools cerebral spinal fluid to reduce injuries associated with spinal and cerebral ischemia
• Technology that manages the exit sites of central venous catheters by promoting the formation of a biological seal around the catheter that blocks the route for bacteria
• Tendon repair device that utilizes a simple and familiar technique to ingeniously join tissue together, with broad applications across a range of surgical sub-specialties
• The first and only wire-independent embolic protection that uses any single guide wire of choice for the entire procedure and seamlessly integrates with standard workflow
• The first passive fetal movement monitor (detector, analyzer, and data logger) for expectant mothers to use at home
• The next-generation brain monitor for safer anesthesia and sedation and improved patient outcomes in Operating Rooms (ORs) and Intensive Care Units (ICUs)
• The TOPS(TM) System is an implantable device that allows axial rotation, lateral bending, extension, and flexion. The implant facilitates bending, straightening and twisting movements at the affected segment of the spine while blocking excessive posterior and anterior sagittal translation.
• The Vortex ZDS(TM) catheter reduces Catheter Associated Urinary Tract Infections (CAUTIs) by at least 50% to replace Foley catheter as the indwelling urinary catheter of choice
• Therapies for the treatment of acute wounds, chronic wounds, scarring, abnormal scarring, inflammation and pain, fibrosis, surgical adhesions, and orthopedic procedures
• Thermal infusion fluid warmer device that enables surgeons to manage and warm up to five fluids at once
• Tissue expander technology that allows both diagnostic and therapeutic capabilities never before available during tissue expansion
• Transcutaneous vagus nerve stimulation to treat patients suffering from drug-resistant epilepsy or other difficult-to-treat neurological and psychiatric disorders
• Ultrasound-based molecular imaging agents that can be used to: 1-diagnose and stage disease, 2-monitor response to therapy in the pharmaceutical research setting, and 3-elucidate the biology of disease processes in the basic science setting
• Unique, patented, activated collagen, CellerateRX(R) for the expanding diabetes and greater wound care markets
• Venous stenting device and ablation technology for the treatment of chronic venous disease
• Versatile, easy-to-use, accurate, and cost effective aorto-ostial stent positioning system to facilitate precise stent implantation in coronary and renal arteries
• Wireless 3G cellular-enabled blood glucose meter that instantly transmits glucose values to a care-management server and provides instant feedback and coaching to patients with diabetes
• Wrist-band glucose monitoring for the detection of hypoglycemia

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