Maryland/Israel Trendlines Israel Fund I, L.P.

Today’s gold standard for correction of spinal deformity (scoliosis) involves fusing an average of 10 motion segments with 20 screws, in a surgical procedure that lasts an average of six hours, costs upward of $100,000, and leaves a long scar and significant loss of spine mobility.ApiFix’s minimally invasive deformity correction system is a breakthrough in treatment of Adolescent Idiopathic Scoliosis (AIS). The system incorporates a miniature ratchet mechanism that captures incremental corrections over time — as the patient performs a physical therapy regiment that allow the soft tissues to accommodate to any minor correction. As opposed to the current procedure, the ApiFix device is inserted through a small incision in the patient’s back and uses only two screws to support the small expandable rod. The result is significantly reduced surgery time, cost, risk, and recuperation period.The global market for AIS implants is $650 million. Implant costs are high ($10,000-$20,000) with high gross margins. There are many players in the scoliosis market, all with products for the current standard procedure. The ApiFix device will offer a strong competitive differentiator for any of these players.

Current aerosol dispensing systems are based on the use of propellants and pressurized gases which pose extensive safety and environmental hazards and increase production and transport costs. Currently, more than 12 billion aerosol units are manufactured worldwide each year, a $40 billion market. Manufacturers and consumers are increasingly interested in cost effective, environmentally-friendly solutions. Regulatory pressure will further help drive adoption of alternatives. GreenSpense has developed a self-dispensing packaging system which eliminates the use of propellants, pressurized gas/air, springs and pumps. The technology is a novel thin, elastic pressure sleeve made of proprietary rubber-nanoclay composites that fits over the standard bag-on-valve system used today. Internally produced pressure replaces the need for chemical propellants. In addition, to alleviating an environmental hazard, GreenSpense simplifies the production process, reduces costs, and opens the way for using different materials, shapes, and sizes of aerosol containers.

During laparoscopic surgery, a clear operative field is critical to safety and efficiency. Laparoscopic retraction — moving obstructing organs away from the target organ — is difficult and expensive to perform. Available technologies often do not create a large enough operative field, increasing both the risk of injury to the surrounding tissue and complication rates. These problems are especially acute in cases requiring bowel retraction.

LapSpace has developed an inflatable balloon retractor that creates a soft, umbrella-shaped basket to retract organs such as the bowel. With adjustable rigidity, the device is safe for internal organs, enables the surgeon to have full control of the retractor size and rigidity, and can be held in place for a long period of time without the need for additional surgical personnel as is done today. The LapSpace technology was developed at Johns Hopkins University; the company operates in Israel.

The total laparoscopy market in 2011 is $6.8 billion. Of the more than 3.5 million procedures performed in the US alone. 850, 000 are relevant for the LapSpace device, creating an addressable market of $180 million in the US and $500 million worldwide.

Only a few thousand of the estimated 30,000 to 60,000 candidates for heart transplant in the U.S. each year actually receive a heart. The ventricular assist device (VAD), an implanted mechanical circulatory pump, is increasingly being used to bridge the time span from end-stage heart failure to transplantation. To supply power to the pump, the VAD is connected to an external power pack by a transcutaneous drive line from the abdomen. Infections related to the drive line are the key challenge to extended VAD use.

Leviticus Cardio has developed a Wireless Coplanar Energy Transfer (CET) system that provides the day-to-day power needs of available VAD implants, while avoiding the complications from infection associated with today’s technologies. Leviticus’ wireless VAD technology is less sensitive to body motion, reduces skin heating as compared to other solutions, and requires a simpler surgical implantation procedure.

The TAM of Ventricular Assist Devices (VADs) is $3 billion to $6 billion, with current sales of $500 million. VAD sales are projected to exceed $1 billion by 2014 with the increased use of VADs as an early-intervention measure in the treatment of heart failure. Only a few companies are active in the VAD market. Leviticus’s technology presents a game-changer in the VAD arena, providing a critical competitive edge to partner VAD manufacturers.

The current standard for treating aortic valve stenosis (AVS) — caused by calcification of the valve — is aortic valve replacement in open heart surgery. AVS is present in more than 25% of patients over age 65 and is associated with a 50% increased risk of cardiovascular events (JACC 2008). Yet only around 30% of the potential population is ineligible for surgery due to the risks for these elderly, weakened patients.

Transcatheter aortic valve implantation (TAVI) is a minimally-invasive procedure in which the aortic valve is inserted through an artery using guiding catheters. TAVI is one of the largest areas of growth in cardiology with a projected market of $2 billion in 2015 (CannacordGenuity). Major players are actively developing valves and acquiring TAVI-related technologies at high values.

Valve positioning is the key challenge in TAVI procedures. Inaccurate positioning can lead to complications and death. Cardiologists currently rely on standard guidewires not specific for the TAVI procedure, insufficient landmarks on X-ray images, and experience.

MediValve’s Valve Positioning System (VPS) provides cardiologists with clear, accurate markers for “first time” TAVI success. Using current procedure protocols, MediValve’s device shortens procedure time and improves outcomes. It opens the TAVI opportunity to less experienced cardiologists and offers a treatment solution for a broader patient population.

Despite intensive efforts by the scientific and pharmaceutical communities, neurodegenerative diseases remain unpreventable, incurable, and largely untreatable. Today, diagnosis is typically carried out through a subjective psychiatric examination at advanced stages of the disease when the damage is significant and the potential for delaying disease progression is low.

NeuroQuest has discovered blood-based immune biomarkers in AD and ALS patients that can be identified using a simple blood test. NeuroQuest’s technology is based on the award-winning research of Professor Michal Schwartz of the Weizmann Institute of Science, who showed that key cellular immunological components in the blood are needed for normal brain function, and that the malfunctioning of these specific cells allows diseases such as Alzheimer’s and ALS to develop and progress. NeuroQuest’s biomarkers may lead to a better understanding of the mechanism of neurodegenerative disease, which in turn could open new directions for improved therapeutics.

One in eight people over the age of 65 have Alzheimer’s. In the U.S., 5.1 million patients represent a diagnostic market of up to $5 billion. Incorporating an accurate diagnostic capable of monitoring disease progression will greatly ease the burden of later-stage diagnosis on families and the health system at large.

Despite advances in processing power, new software algorithms, and better microphones, poor and unreliable performance has relegated speech technologies to marginal penetration of very large and growing markets. Some analysts estimate that automatic speech recognition (ASR) has achieved a mere 15-20% of its market potential.

NovoSpeech has developed proprietary algorithms that modify current state of the art linguistic and acoustic models, overcoming their inherent flaws. Based on an in-depth understanding of speech and signal processing, NovoSpeech’s robust acoustic models utilize minimal processing power, yet precisely evaluate articulation and greatly improve the intelligibility and quality even of degraded speech signals. NovoSpeech’s advanced ASR engine is poised to bring speech recognition mainstream. The Company’s first target application will be voice-activated Bluetooth headsets, serving as a penetration strategy to the ever-growing voice application opportunity in the telephony, automotive, infotainment, and smart home markets.

Benign prostatic hyperplasia (BPH) — enlarged prostate — affects approximately 50% of men over the age of 50 and 80% over the age of 80. BPH causes discomfort and numerous problems with urination. Current BPH treatment options are medication, new minimally-invasive technologies, and surgery – with Transurethral Resection of the Prostate (TURP) the surgical gold standard. All have various drawbacks and side effects. Despite the many treatment options available, the market continues to seek innovative solutions that will decrease hospitalization stay, reduce adverse events, and improve patient quality of life.

ProArc Medical’s ClearRing^TM is a minimally-invasive device designed to treat lower urinary tract symptoms due to BPH. ClearRing expands the urethra by placing supporting implants in the enlarged prostate tissue, thus avoiding any long-term contact with the urine and preventing compression of tissue in the urethral canal. ProArc’s proprietary single-operator device is easy and comfortable for the physician to use and enables continuous visualization during the procedure; it requires a shorter learning curve for the physician and reduces procedure time. The cost-effective ClearRing procedure can be performed in the physician’s office or in other outpatient environments without the need for general anesthesia and hospitalization, resulting in a shorter catheterization and recovery period for the patient.

Each year, an estimated 38 million men with BPH in the US and EU become symptomatic and seek medical attention; 25% have debilitating conditions that require active treatment. The patient population is expected to rise with the increase in the aging population. An estimated 1.5 million BPH procedures will be performed in the US and EU in 2012, resulting in a $1.5 billion market opportunity for ProArc.

For 50 years there has been no major breakthrough in stoma care for ostomy patients. A stoma is an artificial opening in the abdomen in which part of the colon is cut and brought through the abdominal wall for medical conditions including cancer, ulcerative colitis, and Crohn’s disease. The bowel contents automatically pass through this opening and are collected in a bag that is worn 24/7 over the stoma. A typical ostomy appliance includes a shield that protects the skin from the potentially acidic bowel contents, and a disposable bag. People with stoma face numerous obstacles including integration back into society, difficulties with bag management, irritated skin around the stoma as a result of adhesive bags and possible bowel leakage, folliculitis, and embarrassing sounds and odors.

Stimatix™ GI’s Artificial Ostomy Sphincter (AOS-1000™) is a unique device that eliminates the problems inherent in wearing traditional adhesive bags and allows people with stoma to decide, at their convenience, when and where to evacuate. With Stimatix’s AOS-1000™, the evacuation routine is easier, quicker and cleaner, and without skin irritation and folliculitis.

Worldwide there are an estimated 1.3 million people with stoma who use ostomy bags daily. The $2 billion ostomy care market is led by three pouch suppliers: ConvaTec, Coloplast, and Hollister. These three players hold more than 90% of the total market; bags comprise over 90% of the ostomy care market with a CAGR of 4%.

The Trendlines Group establishes, invests in, and develops innovation-based medical and agritech businesses to improve the human condition.  Trendlines is Israel’s leading seed-stage investor, investing principally through its platform of Israeli government-licensed business accelerators. Based in Israel, a recognized hub of innovation and entrepreneurship, Trendlines is uniquely positioned and culturally focused for partnerships to bring Israel’s technologies to international markets.

Trendlines’ leadership is deeply experienced in business development, technology, and finance. Trendlines Business Development brings focused, hands-on business development support to its portfolio companies while Trendlines Labs advises Trendlines’ portfolio companies on technology development and invents technologies to fill unmet market needs.

To date, Trendlines has invested in some 60 companies. Of these, 40 companies have been established in five years, 14 are revenue stage, and two are publically traded on the Tel Aviv Stock Exchange (TASE). After carefully screening approximately 400 technologies, Trendlines invests in 8-10 new companies annually. The Trendlines group and its portfolio companies have realized more than $145 million in financial transactions in five years — including a highly successful exit in 2011.

More than 3 million laparoscopic procedures are performed each year in the U.S. and Europe. A key challenge in performing laparoscopic surgery through smaller incisions and fewer ports is visualization of the target tissue. Yet visualization is often compromised by organs and soft tissue overlaying the desired anatomical target.

Using its proprietary MicroAnchoring™ technology, Virtual Ports has developed a line of patent-protected products that provide secure laparoscopic organ retraction with exceptionally small-profile devices. These products enable faster and simpler positioning, and reduce scarring, pain, port infection, and costs by reducing the total number of ports.

Virtual Ports’ products can be used in a number of laparoscopy markets including cholecystectomy (gallbladder removal), bariatric surgery, colon resection, and robotic surgery. Current market potential is more that 1.5 million procedures in the U.S. alone; the Company estimates its worldwide potential at two to three times that number.

Virtual Ports’ products have FDA, CE, and Japanese approval and are already being used by surgeons in around 50 hospitals in the U.S. With a sales force in the U.S. and a distribution agreement with an established Japanese medical device company, Virtual Ports is now positioned for strong growth.