1 Million Threshold Sp10 Fertility Test for Self Testing
Requirements for Trading Terms
- Shipment TermsDDP
- Target Unit Price1.00 USD
- Payment TermsT/T
Product Description
Otoko is a fast growing company in male thermal contraception with 10000 active users in Europe, projected to reach 50000 by 2026 2027.
Why We Need an IVDR Certified 1M Sperm Test
Unmet Market Need
Men using thermal contraception (or other methods like post vasectomy) need to confirm they maintain a sperm count below 1 million sperm per mL.
Currently, no athome test in Europe specifically targets this low threshold, giving us a clear firstmover advantage.
The lack of testing capacity in Europe (clinical tests are usually around 70 EUR per tests) leads contraception users to go untested and take risks. Hence there is a clear rationale to develop these tests quickly in order to improve public health and contraception efficiency.
2. Commercial Potential
Each user requires 3 to 12 tests per year, translating to 20, 000 to 100, 000 tests per year by 2026.
We have strong community support and can quickly raise up to USD 20, 000 in presales to support initial validation.
Our target cost is around 0, 8 USD per test, making it affordable and scalable.
Proposal: Partnering for IVDR Certification
Objective: Develop a selftest with a 1M per mL cutoff and potentially multiple thresholds (100K, 500K, 1M, 3M) to address broader male fertility monitoring needs.
Regulatory Path: We aim for IVDR (EU 2017 per 746) compliance. Otoko can contribute to the technical documentation and coordinate with a Notified Body.
Funding: While we do not intend to fully finance the entire R&D, we're confident in our ability to raise additional funds for certification steps if needed. This collaboration would reduce both parties' risk and help us launch quickly.
Anything under 200K looks acceptable to finance, in order to go to market within 18 months.
Please reach out if:
You can manufacture custom tests with a 1M threshold
You have CE for self testing under IVDD or IVDR
You are interested in a long term partnership with a fast growing company
You want to cooperate to develop new products for European Markets under IVDR
You can produce double thresholds SP10 tests to test 2 concentrations at a time
3 Audited Suppliers have quoted
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Hebei_Baoding, Hebei
He******
2025-03-19
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Hainan_Haikou, Hainan
Ha******
2025-03-18
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Guangdong_Dongguan, Guangdong
Do******
2025-03-18