Trendlines report: 10 companies to watch Q2 2018

10 companies to watch icon

The report is published quarterly as an aid to understanding the assets of The Trendlines Group.

The 10 companies featured in this report have achieved significant developmental milestones, which may include investments, patent approvals, clinical or field trials, CE mark or FDA clearance, or sales in global markets. The report also includes an update about our Most Valuable Portfolio Company, Stimatix GI.

ApiFix  • BioFishencyEdenShieldFidmi MedicalGordian Surgical • Leviticus CardioMemTechSaturas • ST Stent • Vensica Medical

 

Notes: References appear at the bottom of the page.

ApiFix

Minimally invasive scoliosis treatment device
ApiFix aims to disrupt the scoliosis device market with its minimally invasive, non-fusion spinal implant system for the correction of Adolescent Idiopathic Scoliosis (AIS). Worldwide, there are approximately 126,000 scoliosis procedures per year, of which 40,000 are AIS, representing a US$2.4 billion implant market. ApiFix estimates its total addressable market currently reaches US$1.15 billion.¹

Recent developments

  • Increased the number of surgical procedures to >230
  • Newly issued patent bringing total to 20 issued patents

Status

  • Offices in Boston (U.S.) and Misgav, Israel
  • Targeted sales in Europe, Canada, and Asia
  • CE mark
  • 20 issued patents and further pending patents

BioFishency

Advanced water treatment system for land-based aquaculture
BioFishency’s cost-effective, plug-and-play water treatment system enhances water quality, making it possible to double production in ponds and to reduce water use by up to 95% in tanks. Aquaculture is the fastest growing sector in animal protein production with a market value of US$135 billion in 2015²; 62% of food fish will come from aquaculture by 2030.³

Recent developments

  • Raising US$1.5 million investment round
  • Half-year 2018 sales of ~US$1,000,000, approximately double 2017 full-year sales
  • In process of closing agreement with the Technion Research & Development Foundation Ltd. to license a new technology that will enable growing fish in any temperature (cold, warm) and water type (fresh, sea); will significantly improve the traditional recirculating aquaculture systems (RAS); first application will be for transporting live fish, with the potential for increasing the number of fish and enabling longer transport periods

Status 

  • BioFishency units continuing to operate effectively with increased sales around the world in countries including Israel, China, Bangladesh, India, Congo, and Indonesia
  • Completed large project in China in June 2018 (several systems for over 40 fish tanks); has strong interest for additional units in Nigeria and Vietnam (for the shrimp market)
  • IP: patent in National phase (Israel, China, Europe, India, Brazil)

EdenShield

Natural plant-based crop protection solutions
EdenShield’s natural nontoxic crop protection products leverage characteristics of plants that originate in Israel’s semidesert region to mask plant odor and significantly lower insect attraction, greatly reducing the need for pesticides. The current worldwide insect pesticides market — estimated at US$14 billion, with the greenhouse segment estimated to be at US$2 billion4 — is looking for cost-effective, environmentally friendly solutions that are synergistic with their existing products.

Recent developments

  • Achieved US$208,000 sales in the first half of 2018, – an increase of 28% over first half 2017 sales. US$1.5 targeted sales for 2018
  • Saw significant increases in Q2 product consumption over Q2 2017:
    • EdenNet – 1,200 liters as compared to 90 liters
    • FORTE – 1,200 liters as compared to 75 liters
  • Advanced in regulatory approval in Europe and the United States
  • Received three Israeli government grants – one for reducing pesticide use and two for expanding marketing activities
  • Preparing for sales to the medical cannabis market

Status 

  • Strong distributors in Spain, Greece, Israel, Mexico and California; continuing to expand distribution network in Europe and the United States
  • Strengthening market presence with a jump in installed units
  • Expanding farming operations to meet growing demand
  • Patent granted (U.S., June 2016, Australia, April 2017); published (Europe); final approval stages (Canada, India, Mexico, China); filed (Israel and Kenya)
  • Regulatory approval granted for EdenShield NET and Forte in Spain and Israel; final regulatory stages in Turkey, England, United States
  • Organic certification granted for EdenNET and EdenDIRECT in the UK

Fidmi Medical

Novel feeding device for improved nutrition delivery
Fidmi Medical has developed a uniquely designed, low-profile, enteral feeding device that offers a secure, reliable, and discreet solution immediately post-surgery, and when needed, pain-free removal. Annually, there are approximately 1.3 million enteral device insertions worldwide, and an additional 3 million replacement procedures performed for blocked or dislodged tubes, representing sales of US$540 million. Estimates of the global market will exceed US$600 million by 2018.5

Recent developments

  • Performed 11 procedures
  • Preparing CE mark submission
  • Developing a low-profile PEG device for children

Status 

  • Opened clinical sites in Israel
  • Submitted FDA 510(k)
  • 3 patents pending (all National phase; U.S. EU, China); one patent granted in China
  • Raised US$2 million investment from B. Braun Melsungen AG; funds to be used to complete clinical trials and prepare for market entry

Gordian Surgical

Integrated port closure system
Gordian Surgical has developed and is currently marketing the TroClose1200™, the only integrated port closure system available worldwide. The product enables the surgeon to insert surgical instruments into the abdominal cavity, and then close the port site in a simple, secure, and safe manner when the procedure is completed. The global trocar and closure markets are estimated at a combined US$1.45 billion yearly revenue.6

Recent developments

  • Beginning next investment round
  • Increased usage of the Gordian TroClose™ 1200 to >300 in more than 100 hospitals (including surgical procedures in urology robotics, general surgery robotics, bariatric, gynecology, hernia repair)
  • Direct sales began in the United States beginning Q2 2018

Status 

  • Raised >US$5.5 million to date, including grants
  • FDA regulatory clearance and CE mark certification
  • Portfolio of 3 U.S. patents; two provisional and one in National phase
  • Regulatory clearance in Israel; performed surgeries
  • Regulatory clearance in Mexico; initiated distribution
  • 6 distribution agreements (UK, France, Turkey, Greece, Mexico, Panama)

Leviticus Cardio

Wireless energy system for LVADs
Leviticus Cardio is developing a wireless solution to provide the energy needs of left ventricular assist devices (LVADs), eliminating the need for a driveline, a potential entry point for infection. According to Grand View Research, the global LVAD market was valued at US$763 million in 2014 and is set to grow to US$1.98 billion by 2022, driven by increased prevalence of cardiovascular disease, advances in technology, and favorable reimbursement, among other factors.7

Recent developments

  • Animal trial with successful 80+-day follow-up
  • Successful preclinical study demonstrated wireless power to Jarvik’s fully implanted LVAD
  • Raised additional capital of US$0.5 million

Status

  • Fully operational system
  • Raised US$9.2 million to date
  • 12 issued patents and two pending (U.S.)
  • High visibility among LVAD players
  • ISO 13485

MemTech

Game-changing membranes for water treatment
MemTech’s ultrafiltration membranes have more than 2x higher flux capacity (at similar quality) compared to leading commercial membranes, and are sold for wastewater treatment, pretreatment, drinking water treatment, and nanofiltration. The global membrane wastewater treatment technology market is estimated to reach US$12 billion by 2020 with annual growth of 10.2%.8

Recent developments

  • Proof of concept completed with strategic partner in desalination market
  • Signed agreement with U.S. strategic partner in oil and gas market to provide oil/water separation
  • US$1.9 million raised according to milestone plan

Status

  • Increasing sales of membrane products; initial sales of integrated filtration system; expanding partner relationships and product offerings
  • Growing list of industry partners and of customers include Mekorot (Israel’s national water company) and SEB Alliance
  • IP: 1 issued patent; 2 patents pending (U.S.)

Saturas

Advanced decision support system for optimal irrigation
The Saturas Decision Support System (DSS) for automatic irrigation is based on its miniature Stem Water Potential (SWP) sensor. Embedded in the trunks of trees, vines, and plants, Saturas’ sensors receive direct feedback/input from the tree or vine to provide online, accurate information for optimized irrigation. Current solutions for measuring water status lack accuracy and are labor-intensive or costly.

Recent developments

  • New field trials in California in May 2018 in vineyards, almond, and walnut trees
  • Expanded team; moved to new offices and laboratory in the Trendlines building
  • Updated user interface model – developed and in use

Status 

  • Completed an investment round of US$4 million in Q1 2018
  • Proven technology with Saturas’ sensors successfully operating in lemon, clementine, almond, and apple trees for more than a year
  • ~350 sensors installed in 3 experimental farms and 10 commercials farms in Israel and Spain
  • Established strategic cooperation with Netafim Ltd. and NaanDanJain Ltd. (the leading drip irrigation companies in the world) in Israel, Spain, and California for field trials; these industry leaders are also potential distributors of the system
  • Developed a miniature version designed for vineyards/grape vines; December 2017: new version successfully embedded into plants/vines for wine grapes

ST Stent (STS Medical)

Removable sinus stent for use after Functional Endoscopic Sinus Surgery (FESS)
ST Stent has developed a removable stent for use after FESS to keep the sinus cavity open for almost a month, long enough for the sinus tissue to recover post-surgery. The stent improves patient outcomes and prevents post-surgical complications, thus reducing the probability of revision surgery. Today, about 30% of sinus surgeries fail due to scarring and recurring inflammation that closes the nasal openings and requires revision surgery.9 According to Intersect ENT, the estimated sinus stent market opportunity exceeds $3 billion in the United States.10

Recent developments

  • Mike Berman, a serial medical device entrepreneur and investor, was named Chairman of the Board of Directors
  • First stents successfully implanted and removed in Lenox Hill Hospital, New York
  • Submitted article to American Journal of Rhinology
  • Preparing manufacturing capabilities for first approved product for United States and Israeli markets
  • Preparing for sales in Israel

Status

  • Performed clinical trials (30 patients); including stent removal after four weeks, with three-month follow-up; excellent therapeutic results
  • Raised >US$1.3 million
  • One issued patent (U.S.); two pending (Canada, Europe, Japan, China)
  • Received FDA clearance (December 2017)

Vensica

Ultrasound-assisted drug-delivery for overactive bladder
Vensica Medical is developing VensiCare to treat overactive bladder (OAB) with ultrasound delivering Botox® into the bladder wall painlessly, without needles. The procedure can be performed in the doctor’s office or clinic, without anesthesia. OAB is the most common bladder disorder. There are an estimated 39 million OAB patients in the United States alone11.

Recent development

Clinical trials planned for January 2019

Status

  • Raised US$2 million from Cogentix Medical, part of structured acquisition
  • Successful preclinical trials
  • Filed PCT (international patent application)

References

[1] U.S. National Center for Health Statistics; OECD Health Data 2015; Statistique annuelle des établissements de santé and CNAMTS (Evolution des actes techniques en secteur liberal); Statistisches Bundesamt; Conjunto Mínimo Básico de Datos – Hospitalización and Ambulatorio; UK Hospital Episode Statistics databases for Admitted Patient Care and Outpatients; Life Science Intelligence Surgical Procedure Volume database.

[2] The State of the World’s Fisheries and Aquaculture 2016. Food and Agriculture Organization of the United Nations. https://issuu.com/asgcapbiz/docs/a-i3720e.

[3] “FISH TO 2030 Prospects for Fisheries and Aquaculture.” December 2013. The World Bank. http://www.fao.org/docrep/019/i3640e/i3640e.pdf.

[4] Global Markets for Biopesticides, January 2017. BCC Research.

[5] Enteral Feeding Devices Market: Global Industry Size, Market Share, Trends, Analysis, 2012-2018. Transparency Market Research.

[6] Endoscopic Access Site Closure Devices Market, General and Pelvic Endoscopic Surgery Devices Market, chapter 8. Medical Market and Technology Reports, MeddeviceTracker.

[7] Congestive Heart Failure (CHF) Treatment Devices Market Analysis by Product (Ventricular Assist Devices, Counter Pulsation Devices, Implantable Cardioverter Defibrillators, Pacemakers, Cardiac Resynchronization Therapy) and Segment Forecasts to 2024. October 2016. Grand View Research.

[8] Frost Perspectives: Augmentation of Membrane Filtration Technology Market. June 2016. Frost & Sullivan. https://ww2.frost.com/frost-perspectives/augmentation-membrane-filtration-technology-market.

[9]  RSNA RadioGraphics, Failed Endoscopic Sinus Surgery: Spectrum of CT Findings in the Frontal Recess, 2009. http://pubs.rsna.org/doi/full/10.1148/rg.291085118.

[10] Centers for Disease Control and Prevention. National Center for Health Statistics, Chronic Sinusitis, 2015. https://www.cdc.gov/nchs/fastats/sinuses.htm.

[11] The Burden of Overactive Bladder on US Public Health; Curr Bladder Dysfunct Rep, 2016 March, W. Stuart Reynolds, Jay Fowke, Roger Dmochowski. The Total Economic Burden of Overactive Bladder in the United States: A Disease-Specific Approach; AJMC.com.

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