SB-REG-HORTO – innovative cell therapy for sport and leisure horses

Product description

SB-REG-HORTO is a veterinary candidate biological medicine developed by Sanford Biotech based on mesenchymal stem cells (MSCs) obtained from equine adipose tissue. The product is classified as an advanced therapy medicinal product (vATMP) and is intended for the treatment of orthopaedic injuries, particularly tendon and ligament damage and degenerative joint disease (osteoarthritis).

The preparation will be available in the form of a sterile, deep-frozen cell suspension ready for immediate use after thawing in an "off-the-shelf" formula.

 

Application

SB-REG-HORTO has been developed for sport, recreational and breeding horses suffering from:

  • damage to tendons and ligaments (e.g. flexor digitalis, suspensory ligament),
  • inflammation and degeneration of joints (osteoarthritis, synovitis),
  • chronic lameness, pain and limited mobility,
  • conditions following injuries and orthopaedic procedures.
  • Osteoarthritis and tendinopathies are among the most common causes of sport horses being taken out of training. It is estimated that orthopaedic problems affect more than 60% of working horses during their lifetime.

 

Key benefits

 

  • Reduction of inflammation in the joint and periarticular tissues.
  • Regeneration of tendon fibres and improvement of tissue elasticity.
  • Shortening of the recovery period and faster return to training.
  • Reduction of pain and risk of recurrence of injury.
  • Ready-to-use off-the-shelf product – no need for autologous collection and culture.

How it works

The active substance is a suspension of live, allogeneic mesenchymal stem cells (MSCs) derived from healthy equine donors, intended for intrasynovial or intra-articular injection.

The mechanism of action of MSCs is based on their immunomodulatory and paracrine properties, which enable:

reduction of inflammatory reactions,

stimulation of angiogenesis and type I collagen synthesis,

regeneration of tendon and ligament structure,

protection of articular cartilage against degradation.

As a result, SB-REG-HORTO supports comprehensive regeneration of the musculoskeletal system, rather than merely alleviating symptoms.

Advantages over standard therapies

Standard treatment of injuries in horses – including NSAIDs, steroid injections, rest and physiotherapy – is symptomatic and often leads to recurrence.

SB-REG-HORTO, as a biological therapy, acts causally by rebuilding and modulating tissues. Preclinical studies have shown better tendon regeneration results compared to PRP and traditional steroid therapies.

Note to investors

SB-REG-HORTO is Poland's first cell therapy project dedicated to horses, developed in accordance with EMA/CVMP/VICH GL9 standards. The product fits into the premium veterinary biological medicines segment, which has growing economic potential.

According to data from the European Horse Network, there are over 6 million horses registered in Europe, of which over 1.2 million are sport and race horses. Orthopaedic problems are the cause of up to 40% of all cases of horses ending their sporting careers, which represents a huge market for effective regenerative therapies.

Thanks to its off-the-shelf model and GMP production, SB-REG-HORTO offers high scalability, low distribution costs and rapid clinical implementation.

Scientific evidence and literature

Research conducted by Sanford Biotech and collaborating centres confirms the effectiveness of MSCs in orthopaedic therapy: 

  • Malysz-Cymborska I. i in., Scientific Reports (2021): doi:10.1038/s41598-021-85820-3 
  • Klimczak A. i in., Cell Transplantation (2019): doi:10.1177/0963689719848355 
  • Skwarcz S. i in., Polish J. Vet. Sci. (2019): doi:10.24425/pjvs.2019.127077 
  • Rogujski P. i in., Int. J. Mol. Sci. (2024): doi:10.3390/ijms251910580 

 

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