Trendlines report: 10 companies to watch Q3 2018

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.

ApiFixArcuro MedicalBioFishency • Fidmi Medical • Gordian Surgical • Leviticus Cardio • OrthoSpin • Saturas • ST Stent • ViAqua Therapeutics

Note: 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 >250
  • Earliest treated patients have now achieved six-year follow-up

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

Arcuro Medical

All-suture meniscus repair system

Arcuro‘s SuperBall™ all-suture, knotless, meniscus repair system is based on a technique in which the entire procedure is performed inside the joint space using suture material only and requiring just one entry into the joint. Arcuro’s technology enables simple, effective, reliable meniscus repair addressing an unsolved problem affecting over 2 million meniscal surgeries of the knee annually. The global market (excluding China) is valued at US$300 million, with a CAGR of 13%.²

Recent developments

Completed four successful first-in-human procedures

Status

  • Successful cadaver studies
  • FDA cleared
  • EN/ISO 13485:2012 certified
  • Raised capital from Chinese medical company and U.S. private investors
  • Approved patent in United States and China; pending in Europe and Israel

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 2015³; 62% of food fish will come from aquaculture by 2030.4

Recent developments

  • Raising US$1.5 million investment round
  • 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 

  • H1 2018 sales: ~US$1 million, approximately double 2017 full-year sales
  • BioFishency units continuing to operate effectively with increased sales around the world, including Israel, China, Bangladesh, India, Congo, Nigeria, 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)

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. The worldwide market for Fidmi’s Enteral Feeding Tube is expected to grow at a CAGR of roughly 7.2% over the next five years, reaching US$960 million in 2023, from US$630 million in 2017.5

Status 

  • Performed 11 procedures in Israel
  • Developing a low-profile percutaneous endoscopic gastronomy (PEG) device for children
  • Preparing CE mark submission
  • Submitted FDA 510(k)
  • 3 patents pending (all in 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

  • Continuing next investment round
  • Increased usage of the Gordian TroClose™ 1200 to >500 in more than 100 hospitals (including surgical procedures in urology robotics, general surgery robotics, bariatric, gynecology, hernia repair)

Status 

  • Direct sales began in the United States beginning Q2 2018
  • Raised >US$7 million to date, including grants
  • FDA regulatory clearance and CE mark certification
  • Portfolio of 3 U.S. patents; two provisional, 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

  • Successful completion of chronic animal study in conjunction with a Jarvik heart pump (120-day follow-up)
  • Ongoing animal trials with successful follow-up

Status

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

OrthoSpin

Smart, external, robotic orthopedic fixation system

OrthoSpin offers a new robotic treatment system for use in orthopedics, specifically external fixation. OrthoSpin’s innovative system has the potential to change the outcomes of various orthopedic treatments, such as bone lengthening, setting complex fractures, and correcting deformities. According to company estimates, OrthoSpin addresses the US$450 million market for circular and hexapod fixation frame and other external fixation devices that use adjustable struts.8

Recent developments

Completed US$3 million investment round led by Johnson & Johnson Innovation (JJDC, Inc.)

Status

  • Completed successful first-in-human trial
  • Alpha-version ready
  • IP National phase (U.S., EU, China); 1 provisional patent
  • Chairman Assi Dekel, MD, practicing orthopedic surgeon with more than 13 years’ experience in medical device industry; founded OrthoSpace and NeatStitch

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

  • Completed successful field trials in California (May-October 2018) in vineyards, almond, and walnut trees
  • New field trials in South Africa in vineyards, almond, apple, citrus
  • Based on successful trials, received request from growers in Israel and in California to acquire sensors next irrigation season
  • Based on successful trials, received interest from leading companies for distribution
  • Finalizing sensor assembly procedure for industrial stage

Status 

  • Updated user interface model, developed and in use
  • 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
  • ~500 sensors installed in 3 experimental farms and 10 commercials farms in Israel, California, Spain
  • Established strategic cooperation with Netafim and NaanDanJain (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. Received additional interest from other leading companies in the field

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

  • First stents successfully implanted and removed (New York, Chicago, and Dallas)
  • Exhibited at the annual meeting of American Rhinology Association
  • Published research article in American Journal of Rhinology and Allergy (4 Oct).11
  • Preparing manufacturing capabilities for first approved product for United States and Israeli markets
  • Preparing for sales in Israel
  • Two issued patents (China, Australia)

Status

  • Performed clinical trials (30 patients); including stent removal after four weeks, with three-month follow-up; excellent therapeutic results
  • Named Mike Berman, serial medical device entrepreneur and investor, Chairman of the Board of Directors
  • Raised >US$1.3 million
  • Issued patents (U.S., China, Australia); two pending (U.S., Canada, Europe, Japan)
  • Received FDA clearance (December 2017)

ViAqua Therapeutics

Orally administered health management delivery platform for aquaculture

ViAqua Therapeutics is developing the first orally administered health management delivery platform for shrimp that provides resistance to viral diseases, including White Spot Syndrome Virus (WSSV), and prevents viral epidemics. ViAqua’s first product is for shrimp, the most important aquaculture commodity, which accounts for 20% of the total international trade value of fish products. According to the USDA, diseases cause 10% to 20% losses in shrimp aquaculture. Delivery presents a major challenge for effective, economical treatment.12

Recent developments

  • Proof-of-concept for oral delivery of first product
  • Nutreco NuFrontiers invested in round A funding
  • Signed a joint development agreement with Skretting SA (Nutreco’s aquaculture division) for first product, including distribution and marketing by Skretting
  • Preparing for high-volume manufacturing, including raising necessary funds and investigating collaboration opportunities

Status

  • Finalizing round A investment
  • Expanded team and activity to complete product development and plan for production
  • Set up joint development team with Skretting SA for first product development and project management
  • Product pipeline is in place, utilizing ribonucleic acid interference (RNAi) and delivery platform developed

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] MedDevice Tracker, March 2017.

[3] Food and Agriculture Organization of the United Nations. The State of World Fisheries and Aquaculture. 2014. https://issuu.com/asgcapbiz/docs/a-i3720e

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

[5] Global Enteral Feeding Tube Market 2018 by Manufacturers, Regions, Type and Application, Forecast to 2023. https://www.decisiondatabases.com/ip/25522-enteral-feeding-tube-market-analysis-report

[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. Grand View Research, October 2016.

[8] Trauma Fixation Devices – Global Pipeline Analysis, Competitive Landscape and Market Forecasts to 2017, Global Data.

[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]  A Prospective Study on the Safety and Effectiveness of a Composite Sinus Stent for Use After Endoscopic Sinus Surgery. 2018. American Journal of Rhinology & Allergy. https://doi.org/10.1177/1945892418803101

[12] F.-F. A. A. O. O. T. U. Nations, GLOBEFISH – Update on world seafood markets, Rome, Italy, 2016.