RegenLab’s PRP
What’s PRP?
- PRP stands for Platelet Rich Plasma and is just your own blood separated from white blood cells and red blood cells with a higher platelet’s concentration.
- Platelets are well-known for their clotting abilities; they also contain growth factors that can trigger cell reproduction and stimulate tissue regeneration or healing in the treated area
- The PRP is re-injected using the patient’s own cells to stimulate and accelerate natural healing in a specific area
What's PRP used for?
FDA use:
- The RegenKit®-BCT Family Kit is designed to be used for the safe and rapid preparation of autologous platelet rich plasma (PRP) from a small sample of blood at the patient’s point of care. The PRP is mixed with autograft and/or allograft bone, prior to application to a bony defect for improving handling characteristics.
- The RegenKit®-BCT Family Kits are for single use only.
Off Label:
- PRP injections are being used for a variety of conditions, from sports injuries to hair loss.
- This treatment can address male pattern baldness, stimulate the growth of hair transplants and enhance other cosmetic procedures as micro needling.
- PRP treatments can help support wound healing in trauma and joint or tendon injury, decreasing the pain and enabling a return to activities sooner.
How long will it take to see the results of the treatment?
- The results of PRP treatment are most noticeable after several weeks for joint injections, and six months for scalp injections
- The results are not permanent, patients may require additional injections at the direction of their doctor, and also to see better results it is recommended to continue the treatment on a regular basis each 3–6-month approx.
What are the risks of doing PRP injections?
- Because PRP injections are made up of your own cells and plasma, the risk of an allergic reaction is much lower than with other injectable medications like corticosteroids.
- Less common risks of PRP injections include:
- Bleeding
- Tissue damage
- Infection
- Nerve injuries (When injected)
How do you prepare the PRP?
To create platelet-rich plasma, clinicians take a blood sample from the patient and place it into a device called a centrifuge that rapidly spins the sample, separating out the other components of the blood, from the platelets and concentrating them within the plasma.
How does the Gel Matrix work?
- The centrifuge spins at a specific speed which separates the red blood cells from the Platelet Rich Plasma, it also liquifies the gel matrix.
- When the gel matrix liquifies, the 3 parts are suspended by weight: the red blood cells (being the heaviest) are at the bottom, and the PRP (being the lightest) is at the top. Once the centrifuge stops spinning, the gel matrix solidifies between the PRP and the RBC’s and keeps them separated.
Who is the Manufacturer?
- We are the Authorized Distributors, we work directly with the manufacturer, and count on the support of their clinical specialist’ team.
- Also, the Manufacturer does a vertically integrated process of manufacture, that means that all of the processes are in-house and not third-party (Production – Sterilization – Packaging and Distribution)
Do you have any specials?
- We can offer 12 + 1 kits (purchase 12, get 1 free)
- We can offer a free centrifuge when they need it, and purchase 12 or more kits.
- We can match the price of any FDA approved tube.
- Check the Product Specials Document
Can I use one tube from the kit of 3 for one patient, and use the remaining tubes on other patients?
- Yes, the tubes come in a kit of 3. However, each tube is individually sterilized, and double blister packaged.
- So, you can use each tube for different patients, when you purchase a kit.
Is it accepted by the FDA?
- Yes, FDA 510(K) Clearance: BK110061
- RegenLab® is a Swiss manufacturer of class II and class III medical devices. ISO 13485 and GMP compliant.
How to replace the centrifuge counterbalance?
- Counterbalance replacements are free, you just need to pay shipping
- Black canister holders need to be placed through Drucker directly, the Drucker 1064a Order Form and sent to the contact below, she will also tell you the product number and price.
Contact:
- Elizabeth Hummel
- Customer Service Associate
- Email: elizabeth.hummel@druckerdiagnostics.com
- Tel: +1 814-692-7661 x172
Nitronox
how often should the device backend and how much does that 2-year check cost?
The machine surfaces (focus on outer case, front panel, N2O concentration knob, key lock area) should be wiped down in between patients using Super Sani-Cloth Germicidal Wipes. The breathing circuit, mask, and mouthpiece accessories are considered single-use items unless they use the bacterial/viral filter in which case the patient circuit tubing can be reused. The filter and mouthpiece/mask must still be changed after every use. The inside of the inlets, gas supply hoses, or connection ports should not be cleaned. It comes with a warranty for 3 years of maintenance service (1 each year), after the warranty is $250
Doctors have found that it can be hard to exhale compared to the Pro-Nox tubing. That flap it a little too strong. Anything we can do about this? Or how do we communicate our attributes and why.
One of the safety features of this device is that it’s pneumatically driven and an on-demand system. This means that there will not be a continuous flow of nitrous without need, which could possibly leak out into the general area wasting gas and impacting the provider. There needs to be enough resistance provided by the demand valve so that the user needs to make a conscious effort to inhale/exhale. Quick or shallow breathing (requiring less force) may mean the patient is becoming too light headed or sedated, and the Nox Plus will switch over to regular room air. The Pro-Nox has a recalled mixer and the FDA has recommended using an O2 monitor with the device because the concentration delivered to the patient cannot be verified without an external monitor.
- If the end-user is having a tough time breathing or feels noticeable resistance, then I wonder if there’s something strange with their setup. There really shouldn’t be any huge resistance when breathing the system and I personally haven’t heard this complaint before. If you can take photos of their setup, specifically of their front headpiece gauges when the device is in use, that will help with troubleshooting.
If we open that small valve near top will that make it easier to exhale? What is that small valve for?
The luer-lock on the patient circuit is known as the capnography port. This port is used by anesthesiologists to monitor CO2 return from the patient. For on-demand systems, it is never used and is relevant to continuous flow and sedation systems where the patient isn’t completely conscious. The clean, nitrous oxide mixture is supplied through the lumen of the blue tubing. When the patient exhales, their breath comes through the lumen of the clear portion around the blue tubing, which is where the port is. Opening this valve will not make it easier to breathe through the system and it isn’t designed to be open to the atmosphere. It isn’t connected to the nitrous mixture supply. It is there just for monitoring and it should remain closed for our use. I have never tried to open this port but based on the device’s requirement to have the patient breathing steadily and evenly, I think opening it would make the nitrous supply worse. The exhaled breath may cause the machine’s emergency air intake system to take over and supply just normal room air.
Is there a limit on how long a patient can breathe on the 70/30 mixture?
Nox Plus is considered a transient (less than 60 min) in terms of continuous use (meaning the patient is only breathing in and out of the device) when providing analgesia (minimal to moderate sedation.) Procedures occurring over several hours are also considered transient, and Nox Plus can be safely administered intermittently throughout the duration. Upper limits of use are at the discretion of the providers. When training, I recommend having the patient do a ‘loading dose’ where they breathe the nitrous oxide continuously for at least 5 minutes. Then, they should hold on to the mouthpiece and if they feel pain/anxiety, to take another few hits of the Nox.
- I have never experienced a patient throwing up with the nitrous but nausea is a known side effect of nitrous, especially at higher concentrations. If this happens, you can turn off the nitrous supply and provide straight oxygen to help relieve the symptoms before there’s actual vomiting.
MARKETING QUESTIONS:
- For B2B marketing, we have our Nitronox and Nitronox Plus one pagers. We hand those out at conferences. We can send #25 of each to your sales reps. Please have them request the one pagers with our Customer Service Team at customerservice@plymouthmedical.com. Please note that we only have a limited stock of the legacy Nitronox devices available. Porter no longer manufactures the legacy Nitronox model. Once the remaining legacy models are sold, we will only sell the new Nitronox Plus so it’d make sense for your sales reps to quote the Nitronox Plus to future leads.
- In terms of patient education brochures, we have those available for the Nitronox/Nitronox Plus devices which clients can purchase (100x Brochures $75 + $9.99 shipping). You can find the brochures on our marketing page: https://www.plymouthmedical.com/marketing-msk
- We include information on available marketing in the onboarding email.
Les Encres Threads
Do you offer different types of threads?
Yes, we have 4 types of threads, with different lengths, uses and variations on each:
- Filler Effect:
- Mono (Smooth)
- Screw (Twisted)
- Lifting Effect:
- Cog (Barbed)
- Sculpted (Pressure Molded Barbed) these ones have a larger tensile strength
What are the threads made of?
Les Encres Threads are made of synthetic biodegradable materials. We offer PDO, PLLA and
We are the only provider in the US to carry PCL threads. They are all FDA approved, to be used for surgical sutures:
- PDO (Poly-dioxanone): The most Versatile for Lifting, Volume and Collagen Production, they are cost effective with a higher tensile strength.
- PLLA (Poly L Lactic Acid): Creates Volume to lift the skin with a natural look
- PCL (Poly-caprolactone): They work better for Collagen Production to Increase Volume in the skin as they last more.
- PCL Threads with HA: The HA Boosts the collagen production
How long do they last? are they Absorbable?
They are all absorbable by the body, by hydrolysis and their duration depends on the compound that they are made of:
- PDO (Poly-dioxanone): They have an absorption rate of 6 months, and their effect lasts for 24 months
- PLLA (Poly L Lactic Acid): They have an absorption rate of 8 months, and their effect lasts for 24 months
- PCL (Poly-caprolactone): They have an absorption rate of 24 months, and their effect lasts for 2-4 years
Do you have clinical support?
Yes, to ensure your success, we have a dedicated Clinical Specialist available for you to answer all your questions, and ensure your team is confident and skilled in the art of thread insertion.
Are Les Encres Threads FDA approved?
- Yes, Les Encres is registered with the FDA as a re-packager of FDA approved PDO, PLLA/PCL sutures for soft tissue approximation.
- Les Encres is also the only thread company in the industry to have $1,000,000 liability policies, both General and Product liability.
Do you offer training options?
Yes, we offer 3 training options:
6-hr Custom private session held in the comfort of your own facility – Up to 4 injectors: Requires a minimum order of $4800 + $199 registration fee.
8-hr Intimate group session led by Dr. Jonathan Sykes, at the Roxbury Institute in Beverly Hills, CA – Up to 5 injectors: No minimum order required. $1699 registration fee to confirm session date
- For this option the invoice must be created with the object – Sykes Face Sculpting Institute Session – instead of Canvas Session
- Contact Number: 424-274-2363
- Website: http://www.SykesFaceSculpting.com
- Email: booking@sykesfacesculpting.com
5 days, 40-hr Intensive training led by a highly skilled mentor, at the Wake-Up Beautiful Spa & Academy, Laguna Niguel, CA – $10.000
- Participants may apply a $2,000 voucher to the course or receive $2500 in threads. (Have to confirm)
- For this option the invoice has to be created with the object – Wake up Beautiful Session – instead of Canvas Session
- Contact Number: 888-378-0572
- Website: http://www.wakeupbeautiful.com
Do you have a Rewards Program?
- Yes, The Artistry Points Program offered by Les Encres is a points-based program where active Les Encres Thread users may accrue points to redeem Les Encres discounts and recognition.
- Artistry points may be redeemed for free products and session discounts.
- Points may accrue to become eligible for the Master Les Encres Account designation.
How are the threads inserted?
- Routinely inserted via a 26-30g mounted needle, threads are placed with precision into the subcutaneous (intradermal, hypodermal) layer of the skin, for soft tissue augmentation or lifting.
- Due to the minimally invasive technique and through the use of topical anesthetics, the patient experiences minimal discomfort.
- We have a new blunt tip needle, that allows moving the thread position multiple times before releasing and placing the thread in the right place.
Do you offer any Specials?
Yes, we have Special Introductory Packages:
- Package 1 – 25% discount: $5,733
- Package 2 – 15% discount: $3,499
- Package 3 – 10% Discount: $2,100
Shipping Charges
Each order MUST have one of the following selections added:
- ‘Delivery Fee’ 3-5-day delivery charge for all orders under $1799: $30
- ‘Complimentary 3-5-day Delivery’ charge for all orders above $1800
- Selected ‘Supplemental Overnight Delivery’ if an account would like to upgrade the 3-5-day delivery to overnight*. There is a $40 fee for this upgrade
- ‘Standard Overnight Delivery’ for delivery by close of next business day: $75
- ‘Rush Overnight Delivery’ for delivery by 10:30 am next business day: $95
*All overnight orders MUST be received by 2pm, no exceptions
Refunds, credits or exchanges
- Customer must report any errors and/or discrepancies in orders within 48 hours of receipt, Les Encres is not obligated to issue credit for errors on discrepancies not reported within such time period.
- Refunds or exchanges will not be given on any open pouches of threads or product after 10 days of receipt of order.
- Credit for returned merchandise will be assessed upon receipt of the merchandise and only for items that are authorized for return by Les Encres, LLC. Issuance of a return authorization does not guarantee a credit will be issued.
- Credits will be issued at the original purchase price shown on the invoice or current program price (whichever is less), less the amount of off-invoice allowances or adjustments, including but not limited to a 10% handling charge, restrictions and/or adjustments.
- All credits will be reflected in Customer’s account to apply toward future purchases.