MECHANISM DRIVEN THERAPEUTICS
RESTORING HEALING IN CHRONIC DIABETIC WOUNDS
At WiTii Pharmaceuticals, we are redefining how chronic diabetic wounds are treated; not by adding more signals, but by restoring the biological environment that allows healing to occur. Our work combines drug repurposing with mechanism-driven innovation to unlock new therapeutic potential from known compounds applied in entirely new ways.
THE PROBLEM
A Globally Growing Burden
Millions of diabetic patients suffer from chronic, non-healing wounds.
- Diabetic Foot Ulcers (DFUs) are a leading cause of lower-limb amputations.
Existing therapies fail to consistently achieve durable healing.
Chronic wounds are not just slow to heal— they often fail to heal entirely, triggering a cascade of complications:
- Infection and hospitalization
- Progressive tissue damage
- Amputation
- Increased mortality risk
THE SCALE OF THE PROBLEM
Global:
- 537M+ people living with diabetes
- 19–34% will develop a diabetic foot ulcer (DFU) in their lifetime (1 in every 3 to 5 diabetic patients)
- ~20% of DFU patients require lower-extremity amputation
- ~10% die within one year of their first DFU diagnosis
United States:
40M+
Americans living with Diabetes
(about 12% of the U.S. population )
1.6 M
People affected by DFUs in US annually (Jama Network,2023)
~150K
Amputations/ year linked to Diabetes
(American Diabetes Association)
~1 amputation every 3-4 minutes
$17B
Annual U.S. cost of diabetic limb complications exceeded all cancer types
Diabetic foot ulcers are not just wounds—they are the starting point of nearly 85% of diabetes-related amputations. With early detection and proper care, most complications can be prevented.
WHY THIS MATTERS
Most amputations begin with wounds that fail to heal, even when standard therapies are applied—and the consequences extend far beyond the wound itself:
- Loss of mobility and independence
- Increased risk of mortality
- Significant burden on healthcare systems
OUR SOLUTION
A Precision Mechanism-Driven Therapy
WiTii Pharmaceuticals is developing WiT-001, a small-molecule Cathepsin K inhibitor designed to restore the natural healing environment in diabetic wounds.
Key Advantages:
- Repurposed molecule → de-risked safety profile
- Localized delivery → minimal systemic side effects
- Targets the root cause (excessive protease activity)
- Strong IP protection via method & method-of-use patent
MECHANISM OF ACTION
Breaking the Protease Barrier to Restore Healing
WiTii’s lead candidate, WiT‑001, is a first-in-class, locally delivered therapy designed to address a root cause of chronic wound failure: Excess protease activity that disrupts the body’s ability to heal
THE CORE PROBLEM
In chronic diabetic wounds, Cathepsin K protease become elevated: breaking down the tissue and structure needed for healing & healing stalls due to a destructive molecular environment.
OUR TARGETED SOLUTION
WiTii’s therapy uses local delivery to deliver the drug directly to the wound bed:
- Achieves high local concentration at the site of action
- Minimal systemic exposure, significantly improving safety
- Directly inhibits Cathepsin K, breaking the destructive cycle
Once the protease barrier is removed, the body’s natural healing sequence resumes.
CLINICAL OUTCOMES
- 30%+ faster wound closure (based on founder research)
- Stronger, more functional tissue regeneration
- Reduced risk of amputation and recurrence
- Better quality of life for patients
TEAM
Led by Scientific Innovation & Execution
WiTii’s CSO and Co-Founder, Dr. Sreejayan Nair, is the inventor of the Cathepsin K method-of-use patent underlying our lead program, anchoring our approach in proprietary science. Complementing this,WiTii’s CEO and Co-Founder Anand Shukla brings deep experience across drug development, clinical programs, and commercialization, with leadership roles spanning global pharmaceutical and biotech organizations. Together, this foundation is supported by a multidisciplinary team spanning development, regulatory, and operations—working to translate innovation into real-world therapies.
Advisory Network
We are supported by a high-caliber group of advisors with deep expertise across the key disciplines required to advance WiT‑001 to IND and beyond, including clinical development, regulatory strategy, and commercialization.
WHY NOW
A Large, Growing and Under Served Market
Diabetic foot ulcers (DFUs) represent a large, growing, and underserved global market driven by rising diabetes prevalence, high treatment costs, and persistent gaps in clinical outcomes.
537M+
People living with diabetes globally
IDF Diabetes Atlas, 2021
1 in 3
Will develop a diabetic foot ulcer
Over their lifetime
~20%
Progress to amputation
Of all diabetic foot ulcer cases
~10%
Mortality within 1 year
Following major amputation
MARKET MOMEMTUM
A rapidly expanding market driven by rising diabetes prevalence and persistent clinical gaps
The DFU Treatment Market is projected to grow steadily over the next decade:
- ~$9–10B today → $16B+ over the next decade
- Sustained growth driven by rising prevalence and aging populations
- The U.S. diabetic foot ulcer treatment market alone is projected to grow from ~$1.7B to nearly $3B over the next decade.
CAGR 6.44% · North America share 38.88% (2025) · Forecast period 2026–2034
Fortune Buisness Insights 2025
THE OPPORTUNITY
High Cost Burden
$3K – $17K+
Cost per wound episode
Driven by hospitalizations, surgery, and long-term care
Treatment Gap Persists
Outcomes Remain Inconsistent
Healing failure continues despite multiple available therapies
Innovation Opportunity
Clear Need for Better Solutions
Opportunity for therapies that improve healing reliability and outcomes
The challenge is not the absence of treatment but the failure to restore the biology of healing. Despite its scale, outcomes remain inconsistent creating a clear opportunity for therapies that improve the reliability of healing, not just the availability of treatments.
WiTii addresses this gap through a mechanism-driven, repurposing-based approach designed to restore the biological conditions required for healing to occur.
THE WITII ADVANTAGE
- First-in-Class Mechanism Cathepsin K inhibition targeting a key biological driver of impaired healing.
- Faster Healing Signal ≥30% faster wound closure demonstrated in preclinical studies.
- Localized SafetyLocal delivery approach designed to minimize systemic exposure and risk.
- Cost Efficient Approach Small-molecule strategy offers advantages over expensive biologics and skin substitutes.
- Designed for Adoption Seamlessly integrates into standard wound care workflows.
PROTECTED INNOVATION & PARTNERSHIPS
WiTii’s platform is supported by strong intellectual property and institutional backing:
- Method and method-of-use patents in chronic wound healing
- Exclusive licensing agreement with the University of Wyoming
- Proprietary scientific insights driving differentiated therapeutic applications
ENGAGE WITH WITII PHARMACEUTICALS
We are advancing a differentiated, mechanism-driven approach to chronic wound healing.
Additional information is available through direct engagement.