Hybrid bio-active medical implant coatings

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Barrie Jenkins
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1 Hybrid bio-active medical implant coatings Riga, 2014

2 TECHNOLOGY 3

3 SPHERES OF MEDICAL USAGE Dental surgery Orthopaedic surgery Cardio surgery Reconstructive surgery Plastic Surgery Oncology 4

4 USUAL REHAB TIMELINE This is a schematic demonstration of a usual human rehabilitation timeline after a complicated polytrauma, which would involve an installation of an implant (for ex., screws or plates for reconstructive surgery). As it can be seen, rehabilitation involves multiple risks regardless of an implant type which is being installed. REJECTION CHANCES OF NEW SURGERY INSTABILITY INFLAMMATION LIFE QUALITY DROP 5

, screws or plates for reconstructive surgery).

5 KOATUM S REHAB TIMELINE medical implant coating technology allows to control and minimise these risks. 99% REJECTION SAFE LESS CHANCES OF QUALITY DROP IS SAFE UNDER THE FUNCTIONAL WORKLOAD FULL BONE REGENERATION NO RISK OF INFLAMMATION OR BODY INTOXICATION up to 2X faster healing CHANCES OF NEW SURGERY INSTABILITY INFLAMMATION LIFE QUALITY DROP REJECTION 6

99% REJECTION SAFE LESS CHANCES OF QUALITY DROP IS SAFE UNDER THE FUNCTIONAL WORKLOAD

6 TYPICAL COMPETITOR A typical implant on the market presents either a plain base material product (for ex., pure titanium alloy) or a one-layer coating composition. Coatings, which are being applied, are usually addressing two major aims: - secondary enhancements, such as additional hydrophilic or antiseptic properties. - bioactivity enhancements, which would speed up implant integration. No guarantees of safety, however, are provided. 7

Coatings, which are being applied, are usually addressing two major aims: - secondary enhancements, such as

7 Market, therefore, provides different coating solutions, each of them addressing limited scope of problems and not providing guarantees of safety. Patients, as a result, are not provided with a universally working and safe solution. Manufacturers are also forced to accept the risks of lawsuits and reputation hazard due to patients bodies reacting differently.

Patients, as a result, are not provided with a universally working and safe solution.

8 has developed a multi-layered unique hybrid implant coating solution Two layered composition: - 1st layer completely isolates an implant from the body, making it 100% bioinert - 2nd layer boosts bioactivity and, by slowly dissolving, creates an environment for healthy tissue growth with no inflammations and no barriers for normal healing While the layers complement each other, they possess completely different functions and are created using two distinct methods. They feature excellent adhesion characteristics and cannot be damaged during the surgery 9

growth with no inflammations and no barriers for normal healing While the layers complement each other, they possess completely different

9 We use ANY type of implant material (titanium, zirconium) I PRIMER application (if needed) - implant is being isolated, made 100% bioinert In the case of polymer implants, this step is not needed II Calcium-phosphate applied - implant is given natural bone characteristics and extensive biointegration properties 10

polymer implants, this step is not needed II Calcium-phosphate applied -

10 COATING MODIFIABILITY The second layer of coating can be modified in accordance with the specific implant type or characteristics desired by the customer. The following parameters can be adjusted: I. Thickness II. Speed of coating dissolution in the body III. Coating impragnation with antibiotics (if necessary)

customer. The following parameters can be adjusted: I. Thickness II.

11 CLINICAL TRIAL STATUS 17

12 CLINICAL TRIAL STATUS RUSSIA EU (in-progress) ANIMAL TRIALS >30 dogs and rats sheep (Royal Orthopaedic Hospital, UK) HUMAN TRIALS 13 problematic dental patients 6 orthopaedic negotiations pending 18

13 RESULTS ANIMALS: dogs - 2 months to 3 weeks (functional workload) (broken leg) rats - faster formation of new healthy tissues HUMANS: DENTAL: overall 30-50% healing time decrease, patient with inherited intolerance healed ORTHO: absence of complications, overall 30-50% healing time decrease

DENTAL: overall 30-50% healing time decrease, patient with inherited

14 PROBLEMATIC CASE DEMONSTRATION The X-ray demonstrates dental implants, which were coated using multi-layered method and implanted during limited human trials. The patient had suffered from inherited intolerance of implants before trials started and went through numerous rejections and repeated surgeries. Koatum s solution removed the problem of inherited intolerance and rejection. Implants are well-integrated and working under functional workload for 4 years. 20

The patient had suffered from inherited intolerance of implants before trials started and went through numerous

15 RECENT PUBLIC DEVELOPMENTS Selected as a top-10 start-up Positive response from experts Cleared to participate in Pioneers Festival in Vienna, OCT2014 Among top-24 for 90 Pitch Challenge 24

to participate in Pioneers Festival in Vienna,

16 FUTURE MILESTONES 1) Finalising pre-clinical trials and securing next stage investment 2) Initiation of full-scale orthopaedic and dental human trials. + 3) Start of EU certification process and result introduction to the industry. 25

17 Thank you for your attention Contact us: Sergey Jakimov CEO (Latvia) 27

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