Trendlines report: 10 companies to watch Q4 2017

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.

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

Status

  • CE mark
  • Sales in Europe, Canada, and Asia
  • 7 families of granted and pending patents

BioFishency

All-in-one 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

  • Signed term sheet to raise US$1.5 million from a strategic and private investor
  • 2017 sales of US$550,000
  • Signed term sheet with the Technion-Israel Institute of Technology to license a new technology that will enable growing fish in any temperature (cold, warm) and water type (fresh, sea) and will significantly improve the traditional recirculating aquaculture systems (RAS); first application will be for the transportation of live fish, with the potential for increasing the number of fish and enabling longer transport periods

Status 

  • BioFishency’s units are already operating in China, Indonesia, the Congo, Bangladesh, India, Singapore, Israel, and more
  • Distribution agreements: Bangladesh, India, Taiwan and China; cooperation with several strategic partners
  • IP: patent in National phase

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 synergetic with their existing products.

Recent developments

  • Achieved US$450,000 sales in 2017; an increase from US$110,000 in 2016
  • Established distribution chain in Europe (Spain, Greece, Italy, Turkey, Israel)
  • Raised additional US$2.2 million from strategic and financial investors for increasing production to meet sales growth and for development of a new application
  • Announced strategic partnership with Kibbutz Yotvata in southern Israel to facilitate an increase in production

Status 

  • Ongoing sales in Israel, Italy, Greece, Spain, and Turkey; projected 400% sales growth for 2018
  • Distributor agreements including the United States and Mexico
  • Expanding farming operations to meet growing demand
  • IP: patent granted (U.S., June 2016, Australia, April 2017); published (Europe); final stages (Canada, India, Mexico, China); filed (Israel and Kenya)
  • License granted for EdenShield NET and Forte (Spain and Israel); final licensing stages (Turkey, England, United States)

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

  • Opening two additional clinical sites in Israel
  • Preparing CE mark submission

Status 

  • Successful initial placement of tubes in patients
  • Submitted FDA 510k
  • 3 patents pending (two in National phase; U.S. EU, 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

  • Increased usage of the Gordian TroClose™ 1200 to >200 (in a wide variety of surgical procedures)
  • Regulatory clearance in Turkey; performed surgery, initiated distribution
  • Regulatory clearance in Israel, performed surgery
  • Regulatory clearance in Mexico; initiated distribution, surgery to commence Q1 2018

Status 

  • Portfolio of 3 U.S. patents; one patent in National phase
  • FDA regulatory clearance and CE mark certification in 2016
  • 6 distribution agreements (U.K., France, Turkey, Greece, Mexico, Panama), with monthly shipments; other agreements under negotiations
  • Raised >$5.5 million to date, including grants

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

  • Fully operational system
  • Raised US$6.5 million to date
  • IP: 12 issued patents and two pending (U.S.)
  • High visibility among LVAD players

Status

  • Successful chronic animal trials and integration with LVADs
  • 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

  • Sent first Membrane Bioreactor product unit to Latin America
  • Began a project for the home purification market with a Chinese partner

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

  • Developed a miniature version designed for vineyards/grape vines. In December 2017, the new version was successfully embedded into plants/vines for wine grapes and in citrus trees
  • First user interface model developed and given to farmers for feedback

Status 

  • Proven technology with Saturas’ sensors successfully operating in lemon, clementine, almond, and apple trees for more than a year
  • To date, Saturas has installed ~300 sensors in three experimental farms and six commercials farms in Israel and in Spain
  • Established strategic cooperation with Netafim Ltd. and NaanDanJain Ltd. (the leading drip irrigation companies in the world) in Israel and Spain for field trials; these industry leaders are also potential distributors of the system

New in this report: ST Stent

Removable sinus stent for use after Functional Endoscopic Sinus Surgery (FESS)
ST Stent has developed a removable stent for use after Functional Endoscopic Sinus Surgery (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

  • Received FDA clearance (December 2017)
  • Performed clinical trials (30 patients)
  • Preparing manufacturing capabilities for first approved product for American and Israeli market

Status

  • Successful first in human trials, including stent removal after four weeks, with three-month follow-up; excellent therapeutic results
  • One issued patent (U.S.); two pending (Canada, Europe, Japan, China)

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 developments and status

  • Raised US$2 million investment 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/anadomingues0/docs/fao_state_of_world_fisheries_and_aq.

[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] http://pubs.rsna.org/doi/full/10.1148/rg.291085118

[10] Centers for Disease Control and Prevention. Chonic Sinusitis. 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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