Red Leaf Medical

What Red Leaf Medical does

Red Leaf Medical Inc. is a privately held Canadian specialty healthcare company founded in 2009 and headquartered in Mississauga, Ontario. The company focuses exclusively on urology and infectious disease, commercializing a portfolio of prescription pharmaceuticals, medical devices, and patient support services to Canadian urologists, urology nurses, and patients. Its portfolio spans four therapeutic areas: pelvic floor health (male and female incontinence, catheter supplies), male fertility, recurrent urinary tract and respiratory infections, and pediatric urology. The firm operates as a long-term exclusive licensing and distribution partner to international manufacturers rather than developing assets in-house.

The product portfolio is built on exclusive Canadian agreements with European manufacturers. Flagship assets include UROMUNE (MV140), a sublingual bacterial immunotherapy composed of four whole-cell inactivated bacteria for the prevention of recurrent urinary tract infections, currently awaiting Health Canada approval; BACTEK (MV130), an Inmunotek-developed sublingual vaccine in Phase III for recurrent respiratory tract infections; PROfortil, a patented micronutrient composition licensed from Lenus Pharma for male fertility disorders; and INSTYLAN, a hyaluronic acid bladder instillation product for interstitial cystitis/bladder pain syndrome. Distribution partnerships cover LoFric hydrophilic catheters (Wellspect), Deflux bulking agents (Palette Life Sciences) for vesicoureteral reflux and stress urinary incontinence, and the A.M.I. ATOMS adjustable male continence device. A September 2025 exclusive agreement with Bionorica SE adds Canephron, a non-antibiotic phytopharmaceutical for uncomplicated UTIs, planned for Health Canada submission in Q4 2025 with OTC availability post-approval.

Red Leaf Medical runs a sales-led go-to-market combining direct field engagement with Canadian urologists, specialty pharmacy distribution, and patient-facing divisions CathetersPLUS and ConceptionPLUS, which manage direct consumer ordering, insurance navigation, and clinical support. Revenue is generated through product sales and licensing-driven distribution; financial figures are not publicly disclosed. Founder and CEO Charles Ko has led the company since 2009, and the firm has been recognized on Canadian Business's PROFIT 500 in 2015 (#38, 1,974% five-year revenue growth), 2016 (#28), and 2017 (#233, 258% growth), and on The Globe and Mail's Canada's Top Growing Companies 2025.

Name

Red Leaf Medical

Legal name

Red Leaf Medical Inc.

Website

https://redleafmedical.com

Company type

Private

Founded year

2009

Operating status

Operating

Headcount range

1–10 employees

Short description

Red Leaf Medical is a Canadian specialty healthcare company that distributes and licenses prescription therapies, medical devices, and patient support programs for urology, male fertility, and recurrent infections to providers and patients across Canada.

Ownership category

akta.pro rank

Product category

Urology Therapeutics and Medical Devices

NAICS

Drugs and Druggists' Sundries Merchant Wholesalers (42421)

SIC

Wholesale-Drugs, Proprietaries & Druggists' Sundries (5122), Surgical & Medical Instruments & Apparatus (3841)

akta.pro primary industry

Gastroenterology & Hepatology Pharmaceuticals (HLAIAAAI)

Keywords

• Urology therapeutics
• Pelvic floor health
• Male fertility treatments
• Recurrent UTI prevention
• Medical device distribution

Headquarters

HQ city

Mississauga

HQ country

Canada

HQ region

North America

Offices2 records

Markets served

GTM type

B2B

Offering type

Services

Cost components

Supply Chain, Marketing or Sales, Operations, Personnel, Technology or R&D, Others

Revenue model

1. Pharmaceutical Product Sales: Red Leaf Medical generates revenue through the commercialization of pharmaceutical products and medical devices in the Canadian urology and infectious disease market, including licensed products from international partners.
2. Medical Device Distribution: Distribution of medical devices including catheters (CathetersPLUS division), incontinence devices (A.M.I. ATOMS system, Deflux), and related urology products.
3. Patient Support Programs: Patient support and care services through specialized divisions including CathetersPLUS (catheter patient support) and ConceptionPLUS (fertility support), providing patient information, insurance navigation, and product access.

Go-to-market motion1 record

Distribution channels3 records

Marketing channels4 records

Core offering

Red Leaf Medical is a Canadian healthcare company that commercializes innovative urology and infectious disease therapies and medical devices in Canada. It distributes a portfolio of prescription and consumer healthcare products covering pelvic floor health (male incontinence devices, hydrophilic catheters, hyaluronic acid bladder instillations), male fertility (micronutrient therapy), recurrent urinary tract infections (sublingual bacterial vaccines), respiratory infections, and pediatric urology (vesicoureteral reflux bulking agents). The company also runs patient support programs (CathetersPLUS, ConceptionPLUS) that provide catheter and fertility patients with product information, insurance navigation, and ongoing care.

Product overview

Red Leaf Medical is a Canadian healthcare company specializing in urology and infectious disease, offering a portfolio of innovative therapies and patient support services. The company's products span four therapeutic areas: pelvic floor health (including the A.M.I ATOMS System for male incontinence, CathetersPlus catheter supplies, Deflux for stress urinary incontinence and VUR in children, INSTYLAN hyaluronic acid for bladder instillation, and LoFric hydrophilic catheters), fertility (ConceptionPLUS division offering PROfortil for male infertility), infectious disease (UROMUNE/MV140 sublingual vaccine for recurrent UTIs, BACTEK for respiratory infections, and Canephron in partnership with Bionorica for UTIs), and pediatric urology (Deflux VUR). The company operates through sub-brands including CathetersPLUS and ConceptionPLUS that provide patient support programs alongside their therapeutic products.

Differentiator

Problem solved

Functional benefit

Brands

• CathetersPLUS™: Division of Red Leaf Medical committed to improving lives of patients who use catheters, providing catheter specialists and patient support across Canada.
• ConceptionPLUS™

Products and services

• A.M.I. ATOMS System Adjustable male urinary incontinence system with hydraulic components and a 4-point fixation mechanism, featuring a suburethral cushion that can be post-operatively adjusted without further surgery. Indicated for men with stress urinary incontinence of all degrees, including post-radiotherapy patients. Distributed in Canada via Red Leaf Medical's partnership with A.M.I. (Agency for Medical Innovation).
• CathetersPLUS patient support program Division of Red Leaf Medical committed to improving the lives of patients who use catheters. Catheter specialists are available across Canada to provide exceptional patient support, product information, and insurance reimbursement assistance, including translation services in more than 150 languages.
• Deflux SUI Bulking agent consisting of dextranomer microspheres in hyaluronic acid gel for endoscopic injection under the urethral mucosa to treat stress urinary incontinence in adults. Distributed in Canada via Red Leaf Medical's partnership with Palette Life Sciences.
• Deflux VUR Sterile viscous gel of dextranomer microspheres in stabilized hyaluronic acid indicated for endoscopic treatment of children with vesicoureteral reflux grade II to IV. Distributed in Canada via Red Leaf Medical's partnership with Palette Life Sciences.
• INSTYLAN Hyaluronic acid product for bladder instillation indicated to treat Interstitial Cystitis / Bladder Pain Syndrome (IC/BPS) and radiation-induced hemorrhagic cystitis. User-friendly packaging supports patient self-administration at home. Clinical response rates of 30-87% have been reported for IC/BPS.
• LoFric hydrophilic catheters Hydrophilic urinary catheters using Urotonic surface technology for intermittent self-catheterization, designed for comfort and safety. LoFric was the world's first hydrophilic catheter, launched in 1983. Distributed in Canada through Red Leaf Medical's partnership with Wellspect HealthCare.
• ConceptionPLUS patient support program Division of Red Leaf Medical that provides patient information about the causes of male infertility and offers access to potential solutions such as PROfortil, a Health Canada approved natural health product for male fertility disorders.
• PROfortil Health Canada approved natural health product containing a patented composition of micronutrients for the treatment of male fertility disorders. Backed by five clinical studies with over 750 patients demonstrating improvements in sperm parameters, including a 26% pregnancy rate in couples after 3 months of treatment in a controlled study of 205 patients.
• UROMUNE (MV140) sublingual vaccine Self-administered sublingual vaccine composed of four whole-cell inactivated bacteria (Escherichia coli, Klebsiella pneumoniae, Proteus vulgaris, Enterococcus faecalis) for the prevention of recurrent urinary tract infections in women. Administered as two sprays under the tongue once daily for three months. Clinical evidence shows 75.3% reduction in UTI recurrence over a nine-month efficacy period, with more than 40,000 patients having used the product worldwide through special access programs. Exclusively licensed in Canada from Inmunotek.
• BACTEK (MV130) sublingual vaccine Sublingual bacterial immunotherapy for the prevention of recurrent respiratory tract infections, developed by Inmunotek and exclusively licensed in Canada to Red Leaf Medical. Currently undergoing Phase III clinical development.

Quantifiable outcome

• UROMUNE demonstrated 75.3% reduction in UTI recurrence over nine-month efficacy period; 40.6% UTI-free rate; 80.3% reported moderate/marked improvement at 12-month follow-up
• +2 more outcomes

Named customers3 records

Segments3 records

Ideal customer profiles2 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature4 records

Partnerships

Six partnerships are on record, tiered core and supporting.

• Bionorica SEcoreStrategic or Co-development Partner · 5 September 2025Exclusive partnership to bring Canephron to the Canadian market - a first-line, non-antibiotic treatment for acute uncomplicated UTIs. Currently marketed in over 41 countries with Phase III RCT demonstrating non-inferiority to fosfomycin antibiotic. Red Leaf Medical intends to file Product License Application with Health Canada in Q4 2025.
• InmunotekcoreOEM/ Whitelabel/ Licensing Partner · 1 March 2021Expanded exclusive licensing agreement for Canadian commercialization of UROMUNE (MV140) sublingual vaccine for recurrent UTIs and BACTEK (MV130) for recurrent respiratory tract infections. Original agreement signed October 2017. UROMUNE exclusively licensed in Canada; developed by Inmunotek based in Madrid, Spain.
• Lenus PharmacoreOEM/ Whitelabel/ Licensing Partner · 15 September 2016Exclusive agreement to commercialize PROfortil in Canada - a clinically proven treatment for male fertility disorders containing patented micronutrient composition. PROfortil is a natural health product approved by Health Canada.
• Wellspect HealthCaresupportingChannel Partner/ Reseller/ DistributorPartnership for distribution of LoFric hydrophilic catheters in Canada. LoFric was the world's first hydrophilic catheter (launched 1983) and uses Urotonic surface technology for comfortable catheterization.
• Palette Life SciencessupportingChannel Partner/ Reseller/ DistributorPartnership for distribution of Deflux products for vesicoureteral reflux (VUR) treatment and stress urinary incontinence (SUI) in adults.
• A.M.I. (Agency for Medical Innovation)supportingChannel Partner/ Reseller/ DistributorPartnership for distribution of A.M.I. ATOMS System - an adjustable male urinary incontinence device suitable for all degrees of incontinence including post-radiotherapy patients.

Scale indicators4 records

Recent moves5 records

Expansion highlights4 records

Direct peers

• Searchlight Pharma: Canadian specialty pharmaceutical company focused on licensing and commercializing innovative therapeutics in women's health and urology. Closely comparable to Red Leaf's model of in-licensing European/foreign assets and distributing them in Canada.
• Knight Therapeutics: TSX-listed Canadian specialty pharmaceutical company that in-licenses and commercializes innovative products across multiple therapeutic areas including urology. Directly comparable business model of acquiring Canadian rights to foreign-developed products.
• Acerus Pharmaceuticals: Canadian specialty pharmaceutical company commercializing men's health and urology products including Natesto. Comparable to Red Leaf in therapeutic focus (urology/men's health) and Canadian market presence.
• Pendopharm: Canadian specialty pharmaceutical division commercializing niche products in gastroenterology and women's health. Comparable as a Canadian specialty distribution platform bringing foreign-developed products to the Canadian market.
• Veru Inc. U.S.-based specialty pharmaceutical company focused on urology and oncology indications, including prostate and bladder conditions. Comparable for its urology-focused specialty pharma model and pursuit of differentiated, non-traditional urology therapies.
• Coloplast: Global medical device company specializing in ostomy, continence, and urology care including intermittent catheters. Directly comparable to Red Leaf's pelvic floor health / catheter portfolio (e.g., LoFric distribution partnership).

Broad incumbents

• Astellas Pharma: Global pharmaceutical company with a large urology franchise (Vesicare, Myrbetriq, overactive bladder therapeutics). Comparable as a broader incumbent operating in the same urology prescribers and indications Red Leaf targets, though not a Canadian specialist.
• Ferring Pharmaceuticals: Global specialty pharmaceutical company with a significant urology and reproductive health portfolio. Comparable for overlapping therapeutic areas (urology, fertility) and similar licensing/innovation-driven commercial model.
• Bausch Health: Canadian-headquartered global pharmaceutical company with diverse specialty therapeutic portfolios. Comparable as a Canadian-domiciled pharma operator with specialty distribution capabilities, though much larger and broader than Red Leaf.

Regional players

• Convatec: UK-listed global medical products company with a continence care business. Comparable to Red Leaf's catheter and continence distribution activity, though operating at much larger scale and on a global footprint.

Market position

Strengths4 records

Weaknesses5 records

Competitive moat3 records

Key risks6 records

Key highlights7 records

Customer concentration

Revenue estimate

Valuation estimate

Number of profiles

Profiles1 record

Funding overview

Funding rounds

Investors

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Red Leaf Medical