2015 North America's Top 16 Fast-Growing Medtech Companies: Profiles and Product Highlights
As in previous years, Deloitte released its 2015North America’s Top 500 High-Tech Growth CompaniesThe list, with the largest proportion of companies still coming fromSoftware Developmentindustries, with fewer beingInstruments and MetersVCBeat has promptly compiled a list of companies in the medical device sector, totaling sixteen.
The business domains of these 16 companies are relatively diversified: three are involved in telemedicine/mobile health, two operate in the field of genetic diagnostics and precision medicine, four serve the medical aesthetics and plastic surgery industry, and one is a surgical robotics company.
1.Intersect ENT
Intersect ENT is a high-growth-stage drug-device company that has developed a system to ensure targeted, sustained delivery of therapeutic drugs.Drug-Coated Absorbable Implant Technology. This targeted drug delivery technology is designed to ensure that otolaryngologists can improve patient care.
The company’s initial products are PROPEL and mini-PROPEL, drug-coated implants approved by the U.S. Food and Drug Administration for the treatment of chronic rhinosinusitis.
2.Ellipse Technologies
U.S.-based Ellipse Technologies, headquartered in Aliso Viejo, California, aims primarily to make significant strides in plastic surgery and remotely controlled spinal fusion implants.
The company has developed a remote-controlled distributed system that primarily utilizes magnetic control, thereby effectively reducing the need for postoperative surgical adjustments. The primary objective is to ensure that spinal and orthopedic implants do not significantly deviate from their intended positions after being implanted beneath the skin, while employing a remote, non-invasive approach.
In fact, remote control of implants is quite popular abroad. For instance, remote-controlled breast and spinal implants, as well as MicroCHIPS’ remotely controllable implantable contraceptives, have already seen clinical applications. However, due to medical regulatory constraints in China, widespread practical application may still be some way off.
3.Sequenom
Sequenom, Inc., a U.S.-based company, is a world-renowned specialized manufacturer of high-tech biological instruments and associated reagents. The company is dedicated to the research and development of cutting-edge mass spectrometry-based array genotyping technologies, providing superior solutions for biomedical and molecular medicine research, non-invasive prenatal fetal diagnosis, and their clinical applications.
Currently, Sequenom’s independently developed MassARRAY technology platform enables comprehensive qualitative and quantitative analysis of the genome. By leveraging advanced mass spectrometry techniques, this platform provides unparalleled sensitivity and specificity for genomic research. The MassARRAY platform has been widely adopted by leading genetic research institutions worldwide, including the U.S. National Institutes of Health (NIH), Columbia University Medical Center, the Wellcome Sanger Institute in the UK, the University of Tokyo in Japan, the University of Hong Kong, the Chinese University of Hong Kong, Academia Sinica in Taiwan, BGI Genomics in Beijing, and the Shanghai Institute of Hematology. Sequenom’s genotyping technology is recognized as the gold standard in the field. Its revolutionary high-throughput, cost-effective quantitative DNA methylation analysis technology has established an economical and practical new platform for epigenetics research, garnering extensive attention from the academic community both domestically and internationally.
Sequenom is headquartered in San Diego, California, USA, with branches in Germany, Australia, and mainland China.
On May 30, 2014, the Life Sciences Division of Sequenom, Inc. wasAgena BioscienceCorporate Acquisition.
4.OrthoAccel Technologies
Located in Houston, TexasOrthoAccel TechnologiesThe company is, in fact, a supplier primarily engaged in the manufacturing of orthodontic devices and the provision of related treatment services.
The company's initial product isAcceleDent, according to its introduction, this is the first orthodontic application officially certified by the U.S. FDA. It primarily uses battery-powered vibration to accelerate orthodontic treatment.
Patients receive standard treatment, including tooth extraction and the placement of metal braces, among other procedures. After the braces are fitted, an AcceleDent device is installed to facilitate orthodontic correction; this process can be completed at home. During orthodontic treatment, patients bite down on the device for 20 minutes each day. While in the mouth, the device delivers low-frequency pulsed vibrations to the teeth. These vibrations do not cause discomfort and are barely noticeable to the patient.
Researchers believe that the vibratory forces provided by standard orthodontic treatment enhance the metabolism of alveolar bone and periodontal tissues, thereby making tooth correction faster and more effective. Dr. Dubravko Pavlin, Associate Professor in the Department of Orthodontics at the Health Science Center, stated, “We believe that the application of cyclic loading (vibration control) not only increases the rate of tooth displacement but also lays a solid foundation for achieving more stable orthodontic treatment outcomes.”
5.MobileHelp
MobileHelp is a leading M-PERS (Mobile Personal Emergency Response System) As a supplier and service provider, although headquartered in Boca Raton, Florida, it provides personal emergency response services across all 50 U.S. states.
MobileHelp has developed a range of representative products and services, such as the first medical alert system integrating GSM/GPS technology.DUO; Personal emergency response solutions for households without landline telephone serviceSOLO; and traditional medical alert systemsClassicHelp。
In terms of hardware, MobileHelp’s M-PERS device integrates nationwide wireless voice and data capabilities with Global Positioning System (GPS) technology. This combination enables the provision of real-time medical monitoring services and facilitates rapid tracking and localization when individuals seek emergency assistance.
Additionally, MobileHelp also provides a platform for connecting caregivers and family members.Caregiver Tools, when family members require emergency assistance, caregivers can receive necessary alerts through the Caregiver Tools platform.
6.SurgiQuest
SurgiQuest, founded in 2006 and headquartered in Connecticut, specializes in the design and development of laparoscopic trocars, aiming to eliminate the issues associated with traditional trocars—such as circular seals and duckbill valves—that have persisted since the early 1990s.
Many of the company’s executives hail from United States Surgical Corporation, a pioneer in laparoscopy (i.e., surgical robotics). After years of practical experience, several closely connected executives discovered that SurgiQuest’s technology not only eliminates the hassle of extensive lubrication typically required for conventional trocars, but also frees them from the constraints of cylindrical designs. As they further refined the technology and uncovered additional advantages, these individuals ultimately decided to establish the company.
Following its establishment, the company launched a trocar-free insufflation circulation system.airseal, this is the world's first and only one connected toLaparoscopeandRobotic Surgerycannula-free circulation system. It is reported that with this system, physicians no longer need to worry about pneumoperitoneum-related complications during total laparoscopic hysterectomy, and patients appear to have more stable postoperative conditions and smoother ventilation.
Currently, the company is still continuing to improve this system.
7.TearLab Corporation
TearLab Corporation, founded in 2002 and headquartered in San Diego, California, is a minuscule player among in vitro diagnostic companies. However, its area of research—tear diagnostics—is highly promising.
As a globalTear DiagnosisAs a pioneer, its patented product can detect dry eye disease within just one minute using only 50 nL of tears. The product received CLIA waiver in 2012, and TEAR’s products are currently approved for the diagnosis of dry eye disease in multiple countries and regions, including the United States, the United Kingdom, and Australia. The company is listed on the NASDAQ under the ticker symbol “TEAR.”
TearLab's Patented Tear Testing SystemTearLab Osmolarity System, which can be used to measure the osmolality of the tear film, while tearsOsmolalityIt is regarded as a biomarker associated with dry eye disease. Simply put, dry eye disease can be diagnosed through tears. Patients only need to use the TearLab device to collect 50 nL of tears, and the test results for dry eye disease can be obtained within one minute.
From 2012 to 2014, TearLab reported operating revenues of $3.96 million, $14.65 million, and $19.71 million, respectively, demonstrating robust growth. However, constrained by high R&D expenses, TearLab’s profitability was less impressive, with net losses of $19.31 million, $28.99 million, and $23.72 million for the same period. After reaching a peak market capitalization of $350 million in July 2013, the company’s share price declined steadily, leaving its current market cap at just $67.85 million. Although FDA approval has not yet been obtained, a valuation of under $70 million appears overly conservative given the vast market potential and the innovative nature of its diagnostic technology.
8.GenMark Diagnostics
GenMark Diagnostics is a molecular diagnostics company headquartered in Carlsbad, San Diego County, California, USA. It is dedicated to molecular testing for a range of conditions, including FDA-approved tests for cystic fibrosis.
The current President and Chief Executive Officer of GenMark Diagnostics isHany Massarany ，new ePlexThe system is the company’s latest molecular diagnostics platform, a fully automated solution based on eSensor technology. Compared with GenMark’s original XT-8 platform, the ePlex offers the primary advantage of integrating automatic nucleic acid extraction, amplification, and eSensor detection into a single workflow, enabling rapid genetic testing. Operators need only place patient samples—either raw or minimally processed—into a cartridge to obtain results within 90 minutes, with no manual intervention required during the process. The ePlex system is primarily targeted at the market for diagnosing infectious diseases. Initial diagnostic panels include identification of Gram-positive and Gram-negative bacteria, diagnosis of respiratory tract infections, gastrointestinal infection diagnosis, HCV (hepatitis C virus) genotyping, central nervous system infection diagnosis, and fungal pathogen identification.
9.Inogen
Inogen Inc. is a medical device development company dedicated to the development, manufacturing, and sales of products that provide long-term oxygen therapy for patients with chronic respiratory diseases.Portable Oxygen Concentrator。
Inogen was founded by Allison Perry, who was reportedly inspired to invent the portableInogen oneOxygen Generator. The company was founded during a business school competition at the University of California.
The Inogen One oxygen concentrator compresses air and directs it into molecular sieve beds, where oxygen and nitrogen are separated via pressure swing adsorption (PSA) technology. The extracted oxygen is delivered to the patient, while the nitrogen is vented back into the atmosphere.Pressure Swing Adsorption Technology(PSA) is a cyclic regeneration process, so oxygen will not be depleted; as long as the Inogen One oxygen concentrator is powered on, it will continuously produce oxygen.
10.HeartWare International
HeartWare International is also a U.S. medical device company, incorporated in Delaware on July 29, 2008, with its corporate headquarters located in Framingham, Massachusetts.
Heartware is primarily engaged inMiniature Implantable Heart PumporVentricular Assist Devicedevelopment and production, these products can be used for advanced-stageHeart Failuretreatment.
HeartWare Ventricular Assist System, which primarily includes a ventricular assist device (or blood pump), patient accessories, and surgical instruments, provides circulatory support for patients with end-stage heart failure. At the core of the HeartWare System is a proprietary continuous-flow blood pump, known as the HVAD Pump. This blood pump is a full-output device capable of pumping up to 10 liters of blood per minute. The HeartWare System is typically implanted near the heart, thereby avoiding the abdominal surgery usually required for implantation of similar devices.
The company sells its products directly to heart centers and hospitals, as well as through medical device distributors.
11.Ulthera
Ulthera, Inc., a U.S. company founded in 2004 and headquartered in Mesa, Arizona, is a leading global medical device company focused on the development ofUltrasonic Beauty Device。
Ulthera SystemIt is the first and only skin-tightening device to receive U.S. FDA clearance for a non-invasive aesthetic lifting indication. In China, it is also known as Extreme Ultrasound Facelift, Ellévation, and Ultherapy.
12.Amendia
Amendia is an innovative supplier of medical devices for minimally invasive spine surgery. Founded in 2008, the company initially aimed to create balanced solutions among surgeons, patients, medical devices, and biologics, with the ultimate goal of improving surgical outcomes and saving the lives of spinal patients.
The company's current product portfolio includes: treatments for osteoporosisSavannah-T DualFix, intended to promote cervical spine fusionPhenix Cervical Interbody, reducing muscle damageMarquise MIS Channe, and minimally invasive methods for treating lumbar spinal stenosis
iO-Flex Decompression System。
13.Cynosure
Cynosure is a global leaderLaser EquipmentA company specializing in the research and development of various types ofPathological Skin TreatmentandAestheticsa high-tech laser company that has achieved exceptional results, particularly in the treatment of complex pathological skin conditions such as port-wine stains (red birthmarks), dermal melanocytosis (blue-gray birthmarks), hemangiomas, and congenital melanocytic nevi (black birthmarks). Leveraging its proprietary MultiPlex technology and CAP laser skin rejuvenation techniques, the company holds an absolute leading position globally. It has been granted 36 U.S. patents and has received numerous international awards for dermatological laser technology.
Currently, the company’s laser and radiofrequency devices are widely used in various fields such as plastic surgery, gynecology, otolaryngology, and ophthalmology. Its core product portfolio comprises a range of laser technologies, including gemstone lasers, diode lasers, pulsed dye lasers, Q-switched lasers, intense pulsed light (IPL), and radiofrequency technology. The products are exported to 120 countries, including the United States, Canada, the United Kingdom, China, Japan, and South Korea, through international distributors.
14.ZELTIQ Aesthetics
ZELTIQ Aesthetics, founded in 2005, is a high-tech medical company headquartered in Pleasanton, California, USA, with its core business focused onBeauty and Weight Loss ProductsR&D and commercial operations.
The company possesses independently developedCold Lipolysis Technology Platform, with its flagship product being a cold lipolysis system. This system utilizes a patented cryolipolysis technology that, unlike traditional liposuction, achieves fat reduction and weight loss without the need for surgery, injections, or anesthesia.
Currently, the Zeltiq cryolipolysis system has received FDA clearance in the United States.
15.Unilife Corporation
Unilife Corporation was incorporated in Delaware on July 2, 2009. The company is a U.S.-based designer and manufacturer of medical devices, primarily producingSyringe(Syringe). It collaborates with pharmaceutical and biotechnology companies, aiming to leverage its innovative, highly specialized equipment to enhance the development, regulatory approval, and lifecycle management of their injectable therapies.
Its proprietary equipment serves pharmaceutical companies in a format that can be integrated into filling and packaging processes, which are applicable to the research and development of injectable drugs and vaccines. Pharmaceutical companies are responsible for the safe delivery of drug-device combinations to healthcare professionals and patients, facilitating their administration.
In addition, the company’s strategic partner is Sanofi-Aventis.
16.vasomedical，inc
Vasomedical, the owner of EECP® Therapy—the gold standard in Enhanced External Counterpulsation (ECP) treatment—is a diversified medical technology company focused on the design, manufacture, and sale of medical devices.
EECP is the abbreviation for Enhanced External Counterpulsation, known asEnhanced External CounterpulsationThis technology has been in use in China for a considerable period; however, there remains a significant gap in research compared to international counterparts. Vasomedical Inc. has been continuously developing this technology. The company’s Enhanced External Counterpulsation (EECP) system consists of an air compressor, a computer console, several cuffs, and a treatment bed. During treatment, the patient lies on the treatment bed with cuffs applied to specific areas of the limbs. The cuffs are inflated or deflated in synchronization with the cardiac cycle—specifically, inflated during diastole and deflated during systole. This therapeutic approach increases coronary blood supply, reduces cardiac workload, and enhances blood oxygen delivery while simultaneously decreasing myocardial oxygen demand, thereby achieving the intended therapeutic outcomes.
In the United States, the cost of Enhanced External Counterpulsation (EECP) therapy is reimbursed by Medicare, and many private insurance companies also provide reimbursement for this technology in the treatment of refractory angina. The reimbursement for a 35-hour course of EECP therapy ranges from $5,500 to $7,000.