BioNova

TTO RAS&RUSNANO

Biocompatible synthetic materials based on calcium phosphates for the replacement and regeneration of

bone tissue

LLC «BioNova»

Project Product

2

Our Product

The products in the development are complex solution for bone tissue replacement and regeneration based on synthetic osteoinductive ceramic materials and polysaccharides: New synthetic osteoinductive ceramic materials for replacement of

bone tissue; Polysaccharide barrier membranes.

Problem

• Traditionally, in surgery to recover a lost volume of bone tissue is used allo-and autograft (bone fragments of the donor or the patient's own bone), metals, plastics or synthetic materials (calcium phosphate/polymers);

• Key shortcomings are: graft rejection, possible immune response, low quality of newly formed bone tissue, poor biodegradation kinetics, high price.

Project status

• “Know-how” for volume ceramic material production from octacalcium phasphate.

• Pilot production launched at IMET RAS. • First medical purpose product registered – KGA (osteoplastic

material for bone defect replacement), sales launched.

Business Model

• Sell license for production of medical purpose materials to local and international players.

KGA (registered medical product)

LLC «BioNova» lab at IMET RAS

Product description

3

New synthetic osteoinductive ceramic materials Polysaccharide barrier membranes

Composition Precursor of in vivo biological apatite crystallization (up to 90%) Polysaccharide (sodium alginate)

Qualities

Price: starting at $30/g (3 times lower than competitors).

Porosity up to 70% Strength up to 10-20 MPa Biodegradation period - 3-5 months; Osteoinductive qualities and control of

biodegradation kinetics.

Price: $50/5 membranes (twice as low as competitors price).

Porosity up to 20% Elasticity up to 80% Enhance regeneration of bone tissue snd

Periodontium injuries. Full biodegradation, surgery is not required. Diffuses in 13-14 weeks

ApplicationFilling of small and medium bone cavities of different etiology surgical treatment: oncology (treatment of tumors of the musculoskeletal system), orthopedics, dentistry.

Surgical treatment of deep wounds, osteoplactic orthopedic treatment, traumatology, dentistry.

Project products can be used as complex solution and separately.

Матрикс на основе биополимер

Пористость

Кальцийфосфатная керамика

Взаимосвязь пор

Депо кальция200 мкм

Market and competitive advantage

4

In 2011 market for bone tissue regeneration was $5,1 bn (2008 – $3,6 bn, CAGR– 9%).

2016 market estimate - $9,6 bn (CAGR– 12%). Bone graft will remain the largest segment – $5,3 bn.

Key competitors: Cerasorb, Ceraform, Osteoset, BioOss.

In 2012 Russian market for bone tissue regeneration was $80 mln. The long-term capacity of the Russian market is estimated in $500-600 mln.

Potential license acquirers: Orthovita Corp., Curasan AG, Teknimed, Geistlich, LLC «Med-Ing-Bio». Example:in 2008 Orthovita acquired license for collagen production (Allergan, Inc.) for $5,2 mln and license for Vitagel and CellPaker for $ 9 млн (w/o FDA).

High-quality osteo-integration in defect area.

Biodegradation process is consistent with bone formation process. Full bone defect recovery – 3-6 months.

Osteoinductive material quality – induces bone material formation.

No immune reflex and reoperation. Wide-use application. Low initial cost ($4/g) due to “know-how”.

Market Advantages

59%26%

15% Allograf

Synthetic Bone Grafts Substitutes

Demineralized Bone Ma-trix

Market leaders, 2011

17%

10%

8%56%

MedtronicJ&JGenzymeSynthesStrykerSmith & NephewOther

Market structure (materials), 2011

* Данные Stryker Fact Book 2011

Team& Company

5

CTO: Vladimir Komlev, 36 y.o. Lead researcher at IMET RAS, Doctor of Engineering, laureate of President of Russia Prize in science

and innovation. 12 years of biomaterial research experience, managed >30 Russian and international research

projects.

CEO: Oleg Churilov, 38 y.o. Deputy Director of Technology Transfer Office of RAS and RUSNANO. Experience of execution of deals over $4 mln, funding raise from RUSNANO, nanotechnology

centers etc.

Scientific consultant: Natalia Sergeeva Honored Worker of Science (2010), Professor, DSc The head of the laboratory in the State Organization "Moscow Scientific Research Institute of

Oncology of P.A. Herzen“.

COO: Ekaterina Khodunova, 29 y.o. Investment manager at Technology Transfer Office of RAS and RUSNANO. Raised over $1 mln funding for seed-stage start-ups from nanotechnology centers and Skolkovo.

LLC «BioNova» – founded at 2012.1. Member of technology platform «Medicine of the future», «Skolkovo» resident.2. Applied for EU FP73. Clinical trials of the first product KGA was conducted in MNIOI of P.A Herzen, RONC of N.N. Blokhina, CNIIS.4. Execute customized R&D services. 5. LLC «Med-Ing-Bio» is interested in product distribution.

Investment opportunity Proposal for investors – equity share in LLC

“BioNova”

Investments required –$0,91 mln.

Estimated license price - $3 mln per product.

Project period – 1,5 years.

6

Financial parameters

Investments required, $ mln0,91

WACC 40%

Accumulated net cash flow, $mln 8,9

Project NPV, $ mln 3,5

Project IRR 219,3%

Payback period, years 1,8

Discounted payback period, years 2,0

Key project goals:

Technology development for medical products production.

Pre-clinical studies in vitro и in vivo.

Production of lab-scale lot of goods.

Product technical and toxicological testing under Russian standarts.

Documentation preparation for registration.

Registration of medical product in Russia.

9.0 5.80.6

38.135.5

10.9

Equipment

Rent

Expendables

Salary

Clinical and pre-clinical stud-ies in Russia.

Other

Expenditure pattern, %