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The long-acting, nonhormonal contraceptive - for men.
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February 26, 2015
The race towards manufacturing
One-year rabbit efficacy and reversal study: Check. Baboon pilot work: Check. Baboon mating study in process: Check. Now it's time for a high-quality, final batch of Vasalgel for human trials!

We have been working like mad to get ready to manufacture the Vasalgel product. It is not a simple process and involves a long string of procedures, such as synthesis, device assembly, product qualification, safety testing, packaging, and labeling (see Update Nov. 18, 2014). We have learned a lot along the way. For instance, every step takes longer than seems possible! But it all has to be done right to prepare for regulatory approvals.

We're just about to put down a huge deposit at the best syringe-filling factory in the country-- for their first opening, in July. Then, once the syringes are filled they can be rushed to the stability testing company, which tests how shelf-stable it is, and to the toxicology contractor for the final round of laboratory-based safety tests.

What does this mean? Unfortunately, it's looking pretty unlikely that a clinical trial will be enrolling men before the end of the year as hoped. We anticipate the clinical trial will be pushed off to early 2016 to allow time for all of the necessary steps.

We hate seeing timelines slide (and budgets swell). But we want to be as transparent as possible. We console ourselves that we continue to make tremendous progress in getting Vasalgel closer to market.

Timing update
We're grateful our supporters keep their eyes on the prize: Getting to market, so everybody can have access to Vasalgel. But what if you can't wait-- what if you're trying to make a decision whether to get a vasectomy, for example? Realistically, you should probably figure you won't get into the first small clinical trial next year. With 25,000 men and couples signed up and waiting for news of clinical trials, the larger multi-site trial will also fill up quickly. So that means waiting till Vasalgel is out on the market in 2018 and beyond. Yes, we wish it were sooner-- but we want to be sure you have the most up to date information to be able to make plans for your reproductive healthcare.
Baboon studies continue; crowdfunding
Baboon Grooming
The primate work continues to move forward, with great progress but a few hiccups. Next month, several baboons will have had Vasalgel for 6 months!

All in all, we are pleased with the success of Vasalgel as a contraceptive in the baboon model. Reversal is another story, though. We have been able to work on reversal techniques in a few of the baboons, but they are proving technically difficult. The baboon vas deferens is much smaller and more fragile than in the human and it has been challenging to complete the reversals by flushing solution through the tube to remove the Vasalgel.

We have some ideas about next steps. Knowing reversal was possible in rabbits is what keeps us confident that it can be done again.

We're planning to release the baboon results in May or shortly thereafter, in conjunction with Vasalgel's first official crowdfunding campaign. Time to raise some serious money for manufacturing, and take this to the next level!
Help get Vasalgel to market!

the Vasalgel™ team