Seaforia Sperm Separation System. Product Catalog

Transcription

1 Seaforia Sperm Separation System Product Catalog TM R

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3 Content: ABOUT SEAFORIA Introduction Seaforia Sperm Separation System Seaforia procedure Seaforia Lab Kit Seaforia Lab Kit Duo Seaforia Disposable Kit SCIENTIFIC DATA 27 Seaforia System Efficacy Comparison Seaforia vs Gold standard Seaforia procedure - recomended incubation period Seaforia efficacy - low motile sperm concentration PRODUCT CATALOG Seaforia Heating Device Seaforia Stativ for incubators Seaforia Tip Seaforia Lab Kit Seaforia Lab Kit Duo Seaforia Disposable Kit Distributors 27 3

4 ABOUT SEAFORIA The natural way We strongly believe in providing the optimal environment for nature to take its course. Lotus Bio is a biomedical company. Its principal mission is to make the field of human reproduction more accessible to the public, while maintaining high quality performance. The Seaforia line of products assists fertility treatments to become simple, accessible and successful. 4

5 Accessibility is the key Semen assessment and sperm preparation are done in male fertility laboratories and clinics. OB/GYN doctors located far from fertility laboratories face a real accessibility challenge when performing an IUI procedure. Since accessibility is a key factor in fertility treatments cascade and the Seaforia System enables doctors and healthcare professionals perform sperm separation at the clinic, hence treatments availability expands. The sperm separation procedure can be conjugated to a following IVF, IUI & ICI. 5

6 ABOUT SEAFORIA Seaforia Sperm System Seaforia is designed for doctors clinics, centers and male laboratories. Sperm cells procedure with Seaforia System can be easier, faster and cost yielding a high quality end product, using no centrifugation. The System includes a variety of kits for semen and a Device as a Device Disposable Kit Lab Kit Lab Kit Duo Kits are suitable for semen volume. Seaforia The separators are designed to enable sperm in a unique, simple and easy way. volume Separators 6

7 The semen and medium are inserted into the polypropylene medical graded separator. The separator s design assists the process of sperm separation based on the swim-up technique. Sperm separation can be performed with all approved/cleared sperm medium as commonly practiced. Medium Semen 0.5ml Separator The different volume separators are mounted on the Seaforia Heating Device, a unique heating system that provides conditions such as recommended temperature for the separation procedure. The Seaforia Heating Device eliminates the need for additional lab equipment, hence improves the fertility treatment accessibility. Heating Device Seaforia Stativ Optimized for work with Seaforia Separators, for use in a standard incubator. Seaforia Stativ Lotus Bio Tip Especially designed polypropylene tips for reduction of vacuum forces directed on the bio sample during deposition and drawing. Lotus Bio Tip 7

8 ml ml ABOUT SEAFORIA Seaforia Procedure Sperm Separation in 3 easy steps Unique, simple and easy to operate A natural procedure for sperm cells separation with minimal handling 5ml 4 3 3ml 3ml 5ml 5ml 2.4 Semen 2.4 Semen Medium 2.4 Semen Medium Medium Wait 30min Wait 30min Wait 30minEnd Product End Product End Product ml Separation of the progressively motile sperm cells with high percentage of normal morphology Separator cross section Loading Semen Loading Medium Incubation End Product 8

9 Seaforia Lab Kit For fully equipped facilities Single packed sterile separator designed for semen preparation in labs. Includes 3 sterile Lotus Bio tips suitable for standard luer syringes. With the Seaforia Lab Kit the sperm cells separation procedure conducted in laboratory can be easier, faster and cost effective yielding high quality results. The Lab Kit enables selection of motile spermatozoa for further use in IVF, ICI or IUI procedures. The kits are classified according to the semen sample volume:. Lab Kit 0.5ml 2. Lab Kit.0ml 3. Lab Kit.5ml Seaforia Lab Kit Duo For product catalog & additional details please see page 22 Two packed sterile separators designed for semen preparation in labs. Includes 6 sterile Lotus Bio tips suitable for standard luer syringes. The kits are classified according to the semen sample volume:. Lab Kit Duo.0ml 2. Lab Kit Duo.5ml 3. Lab Kit Duo 2.0ml For product catalog & additional details please see page 23 9

10 ABOUT SEAFORIA Seaforia Disposable Kit All in one solution The Disposable Kit is simple to use and requires minimal handling. It contains all the needed disposables for conducting the procedure and requires no additional lab equipment or mechanical handling. * Seaforia Heating Device and medium are needed. Seaforia Sperm Separation can be performed by doctors and healthcare professionals and can be conjugated to a following IUI procedure, hence improves fertility treatments accessibility. The Seaforia Disposable Kits are classified according to the semen sample volume, ranging from 0.4ml to 4.5ml, and divided into 3 variants in order to optimize the results.. Disposable Kit 0.4ml - 2.3ml 2. Disposable Kit 2.4ml - 3.8ml 3. Disposable Kit 3.9ml - 4.5ml For product catalog & additional details please see pages

11 Procedure planning In order to optimize the performance of the Seaforia Disposable Kits please follow our recommendation below: Choosing the best suited kit according to semen volume: 3.9ml - 4.5ml Semen Disposable Kit 2.4ml - 3.8ml Semen Disposable Kit 0.4ml - 2.3ml Semen Disposable Kit

12 SCIENTIFIC DATA Scientific Data At the end of the Seaforia separation procedure, the medium that initialy contained no sperm cells, becomes sperm-cells enriched. The isolated sperm cells population is characterized by progressive motility and a high percentage of normal morphology (Figure and Table ). Figure (A-E): Semen parameters pre- and post- Seaforia procedure. Sperm cells preparation procedure was conducted using separators with different semen volumes. The semen was evaluated according to standard assessment (WHO guidelines), pre and post separation procedures. Using Seaforia Sperm Separation System in an expanded test (n=75) showed a significant difference in the pre- and post-procedure fractions for the following parameters: Percentage of motile sperm cells (about 90% of the isolated sperm cells were motile, A); percentage of progressively motile sperm cells (about 73% of the isolated motile sperm cells had progressive motility, B); percentage of morphologically normal sperm cells (about 29% of the isolated sperm cells had normal morphology, C); combined with a decrease in head defects (D); and round non-sperm cells concentration (decrease in round non-sperm cells in the post-separation fraction, E). Results are mean + s.e. There is a significant improvement of the morphologically normal spermatozoa post-procedure in comparison to the pre-procedure fraction. Concomitantly, there is a significant decrease in the percentage of head defects post-procedure relative to the pre-procedure population. Table : T-test comparison of basic sperm cells parameters pre- and post-seaforia Sperm Separation fractions using separators with different volumes of inserted semen sample. Sperm parameter Percent of motile spermatozoa (%), n=75 Percent of progressively motile spermatozoa (%), n=75 Morphologically normal spermatozoa (%), n=64 Percent of head defects (%), n=6 Round non-sperm cells ([cell/ml]*0^6), n=75 Pre M + SE 45.26± ± ± ±.6 0.7±0.05 Post M + SE 89.8± ± ± ±.3 0.0±0.004 p<

13 An elite quality population of sperm cells isolated by the Seaforia System demonstrates higher efficacy than Total motile sperm cells threshold From a literature review it is clear that there is a wide range regarding the recommended threshold of total motile sperm cells (TMSC) as an outcome of sperm preparation procedure for IUI and IVF. TMSC ranges from 0.8x0 6 to 5x0 6 [Van Voorhis BJ (200). F, V & V IN OBGYN, MONOGRAPH: 29-3]. An internal survey among professional people within the fertility arena supports a practical threshold of 5x0 6 TMSC, hence it was chosen as a minimal threshold parameter for the Seaforia Sperm Separation procedure efficacy. Figure 2 presents the suggested threshold of 5x0 6 total motile sperm cells as an outcome of sperm preparation of original semen sample which was chosen as a minimal threshold parameter for the Seaforia Sperm Separation System. 23 semen samples with motile sperm cells concentrations ranging from x0 6 (cells/ml) were randomly selected. The average total number of motile sperm cells per.0ml of drawn medium relatively to the minimal treshold of total 5X0 6 motile sperm cells for IUI procedure Total motile sperm cells per ml of drawn medium (x0 6 ) The average total motile sperm cells collected from 3 separators, per ml of drawn medium is 8.59x0 6 (s.e. ±6.58x0 5 ) The minimal threshold of total 5x0 6, motile sperm cells for IUI procedure Figure 2: The average total no. of motile sperm cells in drawn medium (calculated per ml) post Seaforia Sperm Separation procedure (using 3 separators of ml inserted semen sample) at the 23 repetitions, relative to a minimal threshold of 5x0 6 motile sperm cells for an IUI procedure. According to the threshold of 5x0 6 total motile sperm cells as an outcome of sperm preparation procedure of an original semen sample, the average total motile sperm cells collected from 3 separators, per ml of drawn medium is 8.59x0 6 (s.e ±6.58x0 5, n=23), having average progressive motility of 72.67% (s.e ±3.43x0 6, n=23, Figure 2). These features demonstrate that the novel Seaforia System is an excellent vehicle for selectively isolating, in a natural way, the best sperm cells population for fertilizing the ovum using intra-uterine insemination or in vitro fertilization. 3

14 SCIENTIFIC DATA A comparison between the Seaforia TM Sperm Separation procedure and two gold standard sperm preparation procedures (discontinuous density gradient and direct swim-up procedures) Two of the most common sperm preparation procedures are:. Direct swim-up, in which spermatozoa are selected by their ability to swim out of the seminal plasma, by layering culture medium over the liquefied semen. Motile spermatozoa then swim into the culture medium 2. Discontinuous density gradient, in which cells are separated by their density and sperm cells are actively swimming through the gradient material by layering semen sample over density gradient (WHO, 200 ). The two gold standard procedures require laboratory equipment such as a centrifuge and an incubator, and should be conducted by a qualified technician. It is recommended in the WHO (200) 2 to minimize the use of centrifugation as much as possible. Since the Seaforia procedure does not require a centrifugation, a comparison to the two gold standard procedures efficacies was planned: Each semen sample was evaluated by routine laboratory methods and then was used to conduct the preparation procedures. The end products of the preparation procedures were assessed post procedures and post 24 hours of incubation within a closed vial in 37 o C. The results (presented in graph and table ) were analyzed using a student t-test. TM 4

15 TM TM TM Graph : A comparison of sperm cells preparation using Seaforia Sperm Separation System versus discontinuous density gradient (n=9, A-&2) and versus direct swim-up (n=2 from 2 different laboratory tests, B-&2). The same original semen sample was divided into two or three and subjected to sperm cells separation using Seaforia Sperm Separation procedure, Direct Swimup and Discontinuous density gradient. The semen sample was evaluated according to standard assessment (WHO, 999, 200) pre-and post- separation procedures. The final pellets of the discontinuous density gradient and of the direct swim up techniques were re-suspended with the same volume as of the Seaforia Sperm Separation procedure s end product volume. 5

16 SCIENTIFIC DATA Seaforia TM versus Density Gradient & Direct swim-up end products assesment - post 24 hours Table : A comparison between Seaforia TM procedure end product s assessment to the discontinuous density gradient and swim-up procedures end products assessments all post 24h incubation within a closed vial in 37 o C Density gradient procedure post 24h (n=9) Direct swim-up post 24h (n=5) The parameter Sperm cells concentration 0 6 (cells/ml) Motile sperm cells concentration 0 6 (cells/ml) Motile sperm cells percentage (%) Progressively motile sperm cells percentage (%) Grade A motility percentage (%) Round cells concentration 0 6 (cells/ml) Total motile sperm cells 0 6 Total progressively motile sperm cells 0 6 Volume (µl) Seaforia procedure average (mean±s.e) 6.8±.2 0.6± ± ± ± ± ±0. 0.2± ±5.4 Average (mean±s.e) 20.7± ±2. 8.0± ± ±4.6 0.± ±0.9.8± ±5.4 p (vs Seaforia procedure) 0.0 NS NS NS NS NS NS NS - Seaforia procedure average (mean±s.e) Average (mean±s.e) p (vs Seaforia procedure) 6.4± ±5. NS.± ±0.8 NS 23.5±0. 2.6±2.6 NS 4.0±7.8 7±7.3 NS 40.0±2.3 4±4.2 NS 0.05± ±0.02 NS 0.4± ±0.3 NS 0.3± ±0.3 NS 434.0± ±4.9 - Sperm cells vitality percentage (%) Sperm cells Normal morphology (%) Head defects 35.9±0.0 4.± ± ±7. 3.0± ±3.2 NS NS NS 52.4± ± ± ±6.4 NS 80.0± ±6.7 NS Mid piece defects 7.0±.6 7.0±.5 NS 6.4± ±2.5 NS Tail defect 9.0± ±4.5 NS 24.6± ±2.0 NS Cytoplasmic droplet 0±0 0±0 NS 0±0 0.4±0.4 NS 6

17 Summary. Comparing Seaforia procedure versus discontinuous density gradient procedure: a. Seaforia procedure is as good as discontinuous density gradient procedure for sperm preparation concerning parameters as: I. Motile sperm cells concentration II. Percentage of grade A motile sperm cells III. Percentage of progressively motile sperm cells IV. Percentage of normal morphology sperm cells V. Percentage of sperm cells with head defects. VI. Total number of motile sperm cells. VII. Total number of progressively motile sperm cells. b. Seaforia procedure displays an advantage upon discontinuous density gradient procedure concerning parameters as: I. Percentage of motile sperm cells II. Round cells concentration c. In the discontinuous density gradient procedure the parameter of sperm cells concentration is higher than Seaforia procedure. This parameter includes immotile and dead sperm cells and therefore it is a disadvantage. d. Post 24 h Seaforia procedure's end product is as good as discontinuous density gradient procedure's end product for sperm preparation concerning all the parameters detailed in paragraphs a and b. 2. By comparing Seaforia procedure versus swim-up procedure: a. Seaforia procedure is as good as swim-up procedure for sperm preparation concerning parameters as: I. Motile sperm cells concentration II. Percentage of grade A motile sperm cells III. Percentage of progressively motile sperm cells IV. Percentage of normal morphology sperm cells V. Total number of motile sperm cells. VI. Total number of progressively motile sperm cells. b. Seaforia procedure shows an advantage upon swim-up procedure concerning parameters as: I. Percentage of motile sperm cells II. Round cells concentration III. Percentage of sperm cells with head defects. c. In the swim-up procedure the parameter of sperm cells concentration is higher than Seaforia procedure. This parameter includes immotile and dead sperm cells and therefore it is a disadvantage. d. Post 24 h Seaforia procedure is as good as swim-up procedure for sperm preparation concerning all the parameters detailed in paragraphs a, b and c. Conclusion The Seaforia Sperm Separation System for sperm preparation (in the natural way without centrifugation) is at least as good as the two most common sperm preparation procedures (swim up and discontinuous density gradient) by end products comparison. The Seaforia procedure requires no additional lab equipment or mechanical handling such as centrifugation. Since the WHO (200) recommends minimizing the use of centrifugation as much as possible, the Seaforia procedure demonstrate a major advantage. 7

18 SCIENTIFIC DATA Seaforia end products characters following 0, 5, 20 & 30 minutes of incubation, n=82 Seaforia separators of 0.5 &.0ml VERSION 3 Twenty semen samples characterized by sperm cells concentration range of cells/ml, motile sperm cells concentration range of cells/ml and normal morphology percentage range of 6-32% (in average ± , ± and 6.95%±.60%, respectively) were utilized for Seaforia procedure by Lotus Bio s staff using 82 separators of 0.5 and.0ml. The end products were assessed following 0, 5, 20 and 30 minutes of incubation. Their characters (such as percentage of motile sperm cells, progressively motile sperm cells and normal morphology, and round cells concentration) were improved relatively to the original semen sample (data not shown). On average the total number of motile and progressively motile sperm cells and of total number of normal morphology sperm cells after 5 minutes (and 20 minutes) were similar to the results after 30 minutes of incubation ( ± , ± and ± , respectively. See table and graph ). Graph : The assessed characters of the Seaforia end products following varied incubation periods Table : Seaforia end products characters using 0.5 & ml separators following 0, 5, 20 & 30 min. of incubation (mean s.e.) * Since for IVF aplications sperm cells having good motility and morphology are needed, therefore the Seaforia procedure`s end product following 5 min. of incubation is recomended for IVF purposes. 8

19 Seaforia procedure efficacy for semen samples with low motile sperm cells concentration (<5x0 6 ) VERSION 2 The decline of the semen quality over the years is expressed also by the severity of asthenozoospermia; a study of 3729 men demonstrated that there is a significant decrease in the percentage of sperm motility in the 2000s compared with the 980s [Mukhopadhyay D et al (200). Ferti Steril 93: ]. Eighteen semen samples characterized by motile sperm cells concentration lower than 5 06 cells/ml (range of motile cells/ml, in average ± ) were utilized for Seaforia procedure by Lotus Bio s staff using 30 separators of 0.5 and.0ml. The end products were assessed following 30 minutes of incubation. Their characters (such as percentage of motile sperm cells, progressively motile sperm cells and normal morphology, concentration of round cells) were improved relatively to the original semen sample (data not shown). On average the end product s sperm concentration was ± , see table and graph ). Seaforia procedure efficacy for semen samples characterized by low concentration of motile sperm cells (<5x0 6, n=30, + s.e.) Graph : The Seaforia end products (utilizing separators of 0.5 and.0 ml) sperm cells concentration versus original semen sample motile sperm cells concentration. Table : Seaforia end products sperm cells concentration utilizing 0.5 ml and.0 ml (mean ± s. e.) versus original semen sample motile sperm cells concentration (n=30) Original semen sample motile sperm cells concentration ( 0 6, cells/ml) Seaforia end products sperm cells concentration ( 0 6, cells/ml) ± ± The Seaforia procedure is effective utilizing semen samples with motile sperm cells concentration <5 0 6 while using separators of 0.5 and.0ml and 30 min incubation. 9

20 PRODUCT CATALOG Seaforia Heating Device Regulatory: FDA 50k,CE, ISO 3485,900 Optimized for work with Seaforia Separators Working temperature: 37 C +0.5 C Requires minimal working space for operation in lab / clinic Eliminates the need for additional lab equipment Capable of either working with PC USB port or AC power adaptor 5 VDC, 000mA Allows a natural procedure for sperm cells separation with minimal handling Content: 0.5cm 7.3cm qty. A B Heating Device Seaforia Disposable Kit AC power adaptor is not supplied C Instruction for Use Packaging: unit A B C Ref. No. CAT042 Description Seaforia Heating Device Quality testing: Environmental safety and performance testing IEC and IEC Download latest instruction for use - PDF Download latest abbreviated guide - PDF View video guide demonstrating Seaforia procedure Distributor list 20

21 Seaforia Stativ for Incubators Features: Optimized for work with Seaforia Separators For use in a standard incubator Packaging: 3 units Ref. No. Description CAT040 Seaforia Stativ Distributor list Seaforia 0 Tips Pack Regulatory: FDA 50k,CE, ISO 3485,900 Universal luer connector For reduction of vacuum forces directed on the bio sample For bio sample transfer Packaging: 0 tips x 00 packs (total 000 tips per box) Ref. No. Description Shelf life CAT074 Seaforia Tip Box Tips Pack min. 4 months Quallity testing: Human Sperm Survival Assay (HSSA) Cytotoxicity: tested by MEM Elution Mouse Embryo Assay (MEA-test) Download latest instruction for use - PDF Download certificate of analysis per LOT number Distributor list 2

22 PRODUCT CATALOG Seaforia Lab Kit Regulatory: FDA 50k, CE, ISO 3485,900 Lab Kit 0.5ml Content: A 0.5ml Separator B Lotus Bio Tip qty. 3 Optimized for 0.5//.5ml semen volume Can be conjugated to a following IVF, IUI & ICI Optimized for male fertility laboratories and IVF clinics Sperm separation can be performed with all approved/cleared sperm medium as commonly practiced Allows a natural procedure for sperm cells separation with minimal handling A Lab Kit ml Content: A.0ml Separator B Lotus Bio Tip A Lab Kit.5ml Content: A.5ml Separator B Lotus Bio Tip B B qty. 3 qty. 3 Heating Device/Stativ and medium are needed A B Packaging: 50 per box Ref. No. Description Shelf life CAT003 Seaforia Lab Kit 0.5ml - Pack of 50 min. 4 months CAT0032 Seaforia Lab Kit.0ml - Pack of 50 min. 4 months CAT0033 Seaforia Lab Kit.5ml - Pack of 50 min. 4 months Quallity testing: Human Sperm Survival Assay (HSSA) Cytotoxicity: tested by MEM Elution Mouse Embryo Assay (MEA-test) Download latest instruction for use - PDF Download latest abbreviated guide - PDF View video guide demonstrating Seaforia procedure Download certificate of analysis per LOT number Distributor list 22

23 Seaforia Lab Kit Duo Regulatory: FDA 50k, CE, ISO 3485,900 Lab Kit Duo.0ml Content: A 0.5ml Separator B Lotus Bio Tip qty. 2 6 Optimized for 0.5//.5/2ml semen volume Can be conjugated to a following IVF, IUI & ICI Optimized for male fertility laboratories and IVF clinicssperm separation can be performedwith all approved/cleared spermmedium as commonly practiced Allows a natural procedure forsperm cells separation with minimalhandling A A Lab Kit Duo.5ml Content: A 0.5ml Separator B C A B B qty..0ml Separator Lotus Bio Tip C 6 Heating Device/Stativ and medium are needed Lab Kit Duo 2.0ml Content: A.0ml Separator B Lotus Bio Tip qty. 2 6 A A B Packaging: 40 per box Ref. No. Description Shelf life CAT079 Seaforia Lab Kit Duo.0ml - Pack of 40 min. 4 months CAT0240 Seaforia Lab Kit Duo.5ml - pack 0f 40 min. 4 months CAT080 Seaforia Lab Kit Duo 2.0ml - Pack of 40 min. 4 months Quallity testing: Human Sperm Survival Assay (HSSA) Cytotoxicity: tested by MEM Elution Mouse Embryo Assay (MEA-test) Download latest instruction for use - PDF Download latest abbreviated guide - PDF View video guide demonstrating Seaforia procedure Download certificate of analysis per LOT number Distributor list 23

24 PRODUCT CATALOG Seaforia Disposable Kit ml Regulatory: FDA 50k, CE, ISO 3485,900 Optimized for ml semen volume Contains all disposables needed for conducting the procedure Can be conjugated to a following IUI & ICI Can be performed by doctors and healthcare professionals, hence improves the fertility treatment accessibility Sperm separation can be performed with all approved/cleared sperm medium as commonly practiced Allows a natural procedure for sperm cells separation with minimal handling Content: A 0.5ml Separator B.0ml Separator C 0.9ml Pasteur pipette D E F G 5ml syringe + Lotus Bio Tip 3ml syringe + Lotus Bio Tip ml syringe + Lotus Bio Tip 2ml Vial A A A B C D E F G qty. 3 Heating Device and medium are needed Packaging: 8 per box Ref. No. Description Shelf life CAT025 Seaforia Disposable Kit ml - 8 Pack min.4 months Quality testing: Non-pyrogenic (LAL-test) Human Sperm Survival Assay (HSSA) Sterility validation according to ISO 37 Cytotoxicity: tested by MEM Elution Mouse Embryo Assay (MEA-test) Download latest instruction for use - PDF Download latest abbreviated guide - PDF View video guide demonstrating Seaforia procedure Download certificate of analysis per LOT number Distributor list 24

25 Seaforia Disposable Kit ml Regulatory: FDA 50k, CE, ISO 3485,900 Optimized for ml semen volume Contains all disposables needed for conducting the procedure Can be conjugated to a following IUI & ICI Can be performed by doctors and healthcare professionals, hence improves the fertility treatment accessibility Sperm separation can be performed with all approved/cleared sperm medium as commonly practiced Allows a natural procedure for sperm cells separation with minimal handling Content: A 0.5ml Separator B.0ml Separator C.5ml Separator D E F 0.9ml Pasteur pipette 5ml syringe + Lotus Bio Tip qty. 2 3ml syringe + Lotus Bio Tip G ml syringe + Lotus Bio Tip H 2ml Vial A B B C D E F G H Heating Device and medium are needed Packaging: 8 per box Ref. No. Description Shelf life CAT026 Seaforia Disposable Kit ml - 8 Pack min. 4 months Quality testing: Non-pyrogenic (LAL-test) Human Sperm Survival Assay (HSSA) Sterility validation according to ISO 37 Cytotoxicity: tested by MEM Elution Mouse Embryo Assay (MEA-test) Download latest instruction for use - PDF Download latest abbreviated guide - PDF View video guide demonstrating Seaforia procedure Download certificate of analysis per LOT number Distributor list 25

26 PRODUCT CATALOG Seaforia Disposable Kit ml Regulatory: FDA 50k, CE, ISO 3485,900 Optimized for ml semen volume Contains all disposables needed for conducting the procedure Can be conjugated to a following IUI & ICI Can be performed by doctors and healthcare professionals, hence improves the fertility treatment accessibility Sperm separation can be performed with all approved/cleared sperm medium as commonly practiced Allows a natural procedure for sperm cells separation with minimal handling Content: A.0ml Separator B.5ml Separator C 0.9ml Pasteur pipette D E F G 5ml syringe + Lotus Bio Tip 3ml syringe + Lotus Bio Tip ml syringe + Lotus Bio Tip 2ml Vial A B B B C D E F G qty. 3 Heating Device and medium are needed Packaging: 8 per box Ref. No. Description Shelf life CAT027 Seaforia Disposable Kit ml - 8 Pack min. 4 months Quality testing: Non-pyrogenic (LAL-test) Human Sperm Survival Assay (HSSA) Sterility validation according to ISO 37 Cytotoxicity: tested by MEM Elution Mouse Embryo Assay (MEA-test) Download latest instruction for use - PDF Download latest abbreviated guide - PDF View video guide demonstrating Seaforia procedure Download certificate of analysis per LOT number Distributor list 26

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28 TM Authorized Representative: MEDNET GmbH, Borkstrasse 0, 4863 Münster, Germany. Manufactured by: Lotus Bio TM (NYMPHAEA) Ltd. P.O.Box 0443,Ramat - Gan , Israel, info@lotusbio.com, Tel: , Fax: CAT024 Rev 9.2 0/08/208.Copyright 2009 Lotus Bio TM (NYMPHAEA) Ltd. All rights reserved. R